EP3740236A1 - Assistance dans le cadre du traitement de l'insuffisance cardiaque - Google Patents

Assistance dans le cadre du traitement de l'insuffisance cardiaque

Info

Publication number
EP3740236A1
EP3740236A1 EP19700369.2A EP19700369A EP3740236A1 EP 3740236 A1 EP3740236 A1 EP 3740236A1 EP 19700369 A EP19700369 A EP 19700369A EP 3740236 A1 EP3740236 A1 EP 3740236A1
Authority
EP
European Patent Office
Prior art keywords
water content
receptor antagonist
tissue water
vasopressin receptor
dosage
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP19700369.2A
Other languages
German (de)
English (en)
Inventor
Frank Kramer
Wilfried DINH
Daniel FORLER
Hubert TRÜBEL
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bayer AG
Original Assignee
Bayer AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bayer AG filed Critical Bayer AG
Publication of EP3740236A1 publication Critical patent/EP3740236A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0537—Measuring body composition by impedance, e.g. tissue hydration or fat content
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4869—Determining body composition
    • A61B5/4875—Hydration status, fluid retention of the body
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/13—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered from dispensers
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
    • A61B5/4839—Diagnosis combined with treatment in closed-loop systems or methods combined with drug delivery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6823—Trunk, e.g., chest, back, abdomen, hip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/686—Permanently implanted devices, e.g. pacemakers, other stimulators, biochips

Definitions

  • the present invention relates to the treatment of heart failure.
  • a sensor for determining the tissue water content around the chest is used in a person suffering from symptomatic heart failure. If the water content does not normalize for a defined period of time when treated with the standard treatment available, treatment with a VI a / V2 vasopressin receptor antagonist is recommended.
  • the dosage of the Vla / V2 vasopressin receptor antagonist and the duration of treatment with the VI a / V2 vasopressin receptor antagonist can be determined based on the sensor data.
  • HF heart failure
  • the heart In heart failure (HF), the heart is no longer able to supply the tissues of the body with sufficient oxygen and nutrients. The removal of metabolic waste products and carbon dioxide is also disturbed. Depending on the severity and type of heart failure, different symptoms may occur: e.g. Shortness of breath when climbing stairs or during other physical exertions - at an advanced stage already at rest.
  • water retention edema
  • hormones such as adrenaline and norepinephrine, which increase the power of the heart and increase the blood pressure via a constriction of the vessels.
  • the effector hormones of the renin-angiotensin-aldosterone system lead to an increase in blood volume and also to an increase in blood pressure.
  • VI a-mediated vasoconstriction In addition to the retention of water mediated by V2 receptors and the associated unfavorable hemodynamic consequences in terms of increasing the afterload, VI a-mediated vasoconstriction also negatively influences emptying of the left ventricle, pressure in the pulmonary vessels and cardiac output. In addition, on the basis of animal experimental data, the vasopressin is also considered to have a direct hypertrophy-promoting effect on the heating muscle.
  • vasopressin receptors In contrast to the renal effect of volume expansion, which is mediated via activation of V2 receptors, the direct effect on the cardiac muscle is triggered by activation of Vla receptors.
  • the blockade of vasopressin receptors is thus a pathophysiologically meaningful therapeutic approach in heart failure.
  • a first aspect of the present invention is a Vla / V2 vasopressin receptor antagonist for use in a method of treating heart failure in a subject carrying a sensor for determining tissue water content in the body of the person in the thoracic region Sensor-measured water content under applied standard therapy does not fall below a defined critical tissue water content within a defined recovery period.
  • Another object of the present invention is a Vla / V2 vasopressin receptor antagonist for use in a method of treating heart failure in a subject carrying a sensor for determining tissue water content in the body of the person in the thoracic region Dosage of the VI a / V2 vasopressin receptor antagonist and / or the duration of treatment with the VI a / V2 vasopressin receptor antagonist based on tissue water content.
  • Another object of the present invention is a Vla / V2 vasopressin receptor antagonist for use in a method of treating heart failure in a subject carrying a sensor for determining tissue water content in the body of the person in the thoracic region Dosage of the VI a / V2 vasopressin receptor antagonist and / or the duration of treatment with the VI a / V2 vasopressin receptor antagonist to be adjusted during treatment to the tissue water content.
  • Another object of the present invention is a system comprising
  • a sensor for determining the tissue water content in the body of a person in the region of the thorax a sensor for determining the tissue water content in the body of a person in the region of the thorax
  • a transmitter for transmitting sensor data to a receiver
  • the receiver for receiving the sensor data transmitted by the transmitter
  • a dosage determination unit for determining a dosage of a VI a / V2 vasopressin receptor antagonist for the person on the basis of the sensor data and / or a treatment duration determination unit for determining the duration of therapy with the VI a / V2 vasopressin receptor antagonist.
  • Another object of the present invention is a computer program product comprising a data carrier, on which a computer program is stored, which can be loaded into the main memory of a computer system and there causes the computer system to carry out the following steps:
  • a further subject of the present invention is a kit comprising the computer program product according to the invention and a medicament containing several doses of a Vla / V2 vasopressin receptor antagonist.
  • a further subject of the present invention is a method comprising the steps:
  • the present invention utilizes a sensor for determining tissue water content around the thorax of a subject to initiate therapy with a Vla / V2 vasopressin receptor antagonist and / or determine the dosage of the VI a / V2 vasopressin receptor antagonist and / or terminate the successful therapy with a Vla / V2 vasopressin receptor antagonist and / or determine the duration of treatment with a VI a / V2 vasopressin receptor antagonist.
  • a sensor is a technical component that can quantify certain physical or chemical properties and / or the physical condition of its environment qualitatively or as a measured variable. The detected quantity is detected by means of physical or chemical effects and usually converted into a further processable electrical signal. Synonyms for the term sensor used terms are detector, (measurand or measuring) transducer and (measuring sensor.
  • the sensor used according to the invention detects the tissue water content of the body of a person in the region of the thorax (thorax) directly or indirectly.
  • the sensor may detect one or more values of a magnitude that correlate to the tissue water content in the region of a person's chest.
  • “Correlation” means that the tissue water content in the region of the ribcage can in principle (possibly after a calibration) be calculated from the corresponding size. The correlation can be positive (with increasing values of the measured size also the tissue water content increases) as well as negatively (with increasing values of the measured size the tissue water content decreases).
  • the senor is preferably worn permanently on (e.g., as a so-called “wearable sensor”) or in the body of the person (e.g., as an “implantable sensor”).
  • the sensor is not continuously carried by a person but is used at defined times by the person suffering from cardiac insufficiency.
  • the senor measures the water content (directly or indirectly) continuously.
  • a single measurement requires a certain amount of time.
  • continuous means that the sensor performs a large number of individual measurements over a period of investigation, which usually extends over several days to weeks, whereby the time interval between two successive individual measurements is so small that a temporal development of the individual and interpolation to areas between the individual measurements is possible (as opposed to taking measurements at longer intervals, which represent only snapshots, but from which no reliable conclusions can be drawn on the course of the size between the snapshots).
  • the tissue water content is measured via the (intra- or transthoracic) impedance. Sensors for measuring intra- or transthoracic impedance are commercially available.
  • tissue water content in the area of a person's chest will be maintained for an extended period, i. tracked over a period of several days to several weeks.
  • tissue water content and / or changes in tissue water content around the thorax are / will be used as biomarkers for initiating therapy with a Vla / V2 vasopressin receptor antagonist and / or for determining the dosage of a Vla / V2 vasopressin receptor antagonist and / or used to determine the duration of therapy.
  • any other therapeutic regimen for the treatment of heart failure than the administration of a VI a / V2 vasopressin receptor antagonist in this specification will be referred to as a standard therapy.
  • the standard therapy is monitored by means of a sensor for determining the tissue water content in the area of the thorax. In the event that the therapeutic measures do not result in a decrease in tissue water content, therapy with a VI a / V2 vasopressin receptor antagonist is initiated.
  • the critical tissue water content value may be set (defined) by a physician, for example.
  • a definition (definition) of the critical tissue water content value for each individual patient is preferably carried out automatically and specifically based on patient data.
  • Patient data that can be used to establish a critical tissue water content value include, for example: gender, age, weight, weight change, height, severity of heart failure (for example, in the New York Heart Association's (NYHA) Division of the New York Heart Association) Class NYHA 1 to IV), history, type and duration and amount of drugs already taken, blood pressure, central venous pressure, respiratory rate, dyspnea, comorbidities, tissue water content in the chest area and the like.
  • NYHA New York Heart Association's
  • Patient data may be entered into a database by a physician and / or nursing staff and / or the patient themselves and / or relatives, if necessary via a network. But they can also be detected automatically by one or more sensors.
  • the critical tissue water content need not necessarily be a value for the tissue water content in the chest area; it is also conceivable that it is the value of a size that correlates with the tissue water content in the breast area. "Correlation" means that the tissue water content in the chest area can be calculated in principle (if necessary after calibration) from the appropriate size.
  • the recovery period may be set (defined) by a physician, for example.
  • a determination (definition) of the improvement period for each individual patient preferably takes place automatically and specifically based on patient data.
  • Patient data that can be used to establish a recovery period are, for example: gender, age, weight, weight change, height, severity of heart failure (for example, in the form of a classification into NYHA classes 1 to IV), anamnesis, type and duration and amount already medications, blood pressure, central venous pressure, respiratory rate, dyspnoea, comorbidities, tissue water content in the chest area, and the like.
  • the critical tissue water content value and / or the improvement time period are not fixed values, ie values which can not be changed with respect to time, but are preferably automatically adapted over the course of time to the state of health of the patient.
  • the critical tissue water content value and / or the improvement period are automatically determined on the basis of patient data and / or automatically adjusted on the basis of patient data in the course of the disease.
  • the duration of treatment with the VI a / V2 vasopressin receptor antagonist based on the sensor data may preferably be automated.
  • a definition (definition) of the duration of treatment for each individual patient additionally takes place on the basis of further person-specific patient data.
  • Patient data that can be used to determine a duration of treatment include, for example: gender, age, weight, weight change, height, severity of heart failure (for example, in the form of a class NYHA I to IV), anamnesis, type and duration and amount already medications, blood pressure, central venous pressure, respiratory rate, dyspnoea, comorbidities, tissue water content in the chest area, and the like.
  • the duration of treatment with a Vla / V2 vasopressin receptor antagonist is not fixed, i. temporally unchangeable value, but is preferably adjusted automatically over time to the health of the patient.
  • the dosage of Vla / V2 vasopressin receptor antagonist is automatically determined based on the measured tissue water content in the region of the person's chest.
  • drug is understood to mean the specification of the drug to be administered, the particular amount of the drug (e.g., a tablet or 2g or IMF or the like) and the frequency of drug administration (e.g., once a day or before each meal or the like).
  • a determination (definition) of the dosage for each individual patient preferably takes place automatically on the basis of person-specific patient data.
  • Patient data that can be used to establish a dose include, for example: gender, age, weight, weight change, height, severity of heart failure (for example, in Form of classification into classes NYHA I to IV), history, type and duration and amount of drugs already taken, blood pressure, central venous pressure, respiratory rate, dyspnea, comorbidities, tissue water content in the chest and the like.
  • the dosage with a VI a / V2 vasopressin receptor antagonist would not be firm, i. temporally unchangeable value, but is preferably adjusted automatically over time to the health of the patient.
  • termination of therapy with a Vla / V2 vasopressin receptor antagonist is preferably determined automatically on the basis of the measured tissue water content in the area of the person's chest.
  • tissue water content in the area of the thorax falls within a range which is defined as the normal range.
  • the dosage is set to zero and therapy with the VI a / V2 vasopressin receptor antagonist is complete.
  • a definition (definition) of the normal range for each individual patient is based on person-specific patient data and preferably automated.
  • Patient data that can be used to determine a dose include, for example: gender, age, weight, weight change, height, severity of heart failure (for example, in the form of a classification into NYHA classes 1 to IV), history, type and duration and amount already medications, blood pressure, central venous pressure, respiratory rate, dyspnoea, comorbidities, tissue water content in the chest area, and the like.
  • the normal range is not fixed, i. temporally unchangeable range of values, but over the course of time is preferably adapted automatically to the health of the patient.
  • the VI a / V2 vasopressin receptor antagonist may be a substance (an agent) that targets both the VI a-vasopressin receptor and the vasopressin 2 receptor (dual vla / vasopressin V2). receptor antagonist); but it may also be a mixture or a multi-component system comprising two or more substances (active ingredients), of which one substance (one active ingredient) addresses the vla vasopressin receptor and another substance (another active ingredient) the vasopressin V2 Receptor addressed. Preferably, it is a dual Vla / V2 vasopressin receptor antagonist.
  • VI a / V2 vasopressin receptor antagonists are described in: WO07134862, WO16071212, WO9944613, WO0247679, WO08036755, WO08036759, WO09117144,
  • VI a / V2 vasopressin receptor antagonist designated BR 6819 (https://adisinsight.springer.com/drugs/800050780).
  • the system according to the invention comprises those components which are at least necessary in order to implement the invention technically.
  • the system according to the invention comprises at least one sensor for determining the tissue water content in the body of a person in the region of the thorax and a transmitter for transmitting sensor data to a receiver and a receiver for receiving the sensor data transmitted by the transmitter and a dosage determination unit for determining a Dosing a Vla / V2 vasopressin receptor antagonist for the individual based on the sensor data and / or a treatment duration determination unit for determining the duration of therapy with the Vla / V2 vasopressin receptor antagonist on the basis of the sensor data.
  • the sensor and the transmitter are components of a single device, the sensor unit.
  • the sensor unit usually comprises a control unit for controlling the measurement value acquisition and transmission of measured values.
  • the sensor unit usually comprises a power supply in order to supply the sensor, the transmitter, the control unit and optionally further components of the sensor unit with energy, preferably with electrical energy. It is conceivable that the sensor unit has input means and / or output means to enable operation by a human user.
  • the receiver and the dosage determination unit and / or the treatment duration determination unit are components of a single device that is not identical to the sensor unit, the evaluation unit.
  • the evaluation unit may be, for example, a commercially available computer that is configured for dosing determination and / or treatment duration determination. In such a computer may be, for example, a workstation or personal computer (personal computer short: PC), which is used for screen work. It can also be a mobile device such as a tablet computer, a smartphone, a laptop, a smartwatch or the like.
  • the evaluation unit receives sensor data by means of the receiver from the sensor unit and can determine a dosage and / or the duration of a treatment.
  • the evaluation unit can check on the basis of the transmitted sensor data whether the tissue water content of the person has already normalized. For example, the evaluation unit can check whether after a defined period of time (recovery period) has elapsed defined value (the critical tissue water content value) has been exceeded or not. If the value has fallen below no therapy with a VI a / V2 vasopressin receptor antagonist is required; the specified dosage is "zero".
  • Vla / V2 vasopressin receptor antagonist therapy is recommended and dosing with a VI a / V2 vasopressin receptor antagonist is not equal to zero.
  • the dosage determination unit of the evaluation unit may dose based on the received sensor data and optionally on a basis determine further patient-specific data.
  • the treatment duration determination unit of the evaluation unit can determine a duration of the therapy with a Vla / V2 vasopressin receptor antagonist on the basis of the received sensor data and optionally on the basis of further patient-specific data.
  • Patient data that can be used to determine a dosage and / or duration of treatment are, for example: sex, age, weight, weight change, size, severity of heart failure (for example, in the form of a classification into classes NYHA I to IV), anamnesis, species and Duration and amount of medications already taken, blood pressure, central venous pressure, respiratory rate, dyspnoea, comorbidities, and the like.
  • the evaluation unit displays the determined (fixed) dosage and / or the specific (fixed) treatment duration on one screen and / or stores it in a database and / or to another computer, e.g. transmitted to the attending physician or other medical staff.
  • the particular (fixed) dosage is communicated to a dosage system that automatically provides the appropriate dosage to the individual suffering from heart failure.
  • a dosing system may be a system that automatically administers the appropriate dosage to the subject (a defined amount of a defined drug at defined times).
  • it may also be a system that reminds the person at defined times (e.g., by an audible and / or visual and / or haptic signal) to take a defined amount of a defined drug; the system may also be configured to provide the defined amount of the person (e.g., by ejecting a defined amount of tablets from a container).
  • the tissue water content value will reach a value within a defined range Range (normal range)
  • the dosage is set to "zero", ie the treatment with the VI a / V2 vasopressin receptor antagonist is terminated.
  • a person suffering from heart failure is hospitalized.
  • the person is equipped with a sensor to determine the tissue water content in the chest area.
  • a doctor and / or nurse inputs patient data of the person into an evaluation unit, which can receive sensor data from the sensor.
  • Patient data can also be collected automatically using one or more sensors.
  • the evaluation unit is configured to calculate a recovery period and / or a critical tissue water content value and / or a normal range for the tissue water content value on the basis of the patient data and / or the sensor data.
  • the calculation can be carried out, for example, on the basis of an expert system.
  • An expert system is a computer program that can assist people in solving more complex problems like an expert by deriving action recommendations from a knowledge base.
  • if-then relationships human knowledge (relationships in the world) can be implemented on a computer and made widely available (knowledge base).
  • the if-then relationships can be developed, for example, through interviews with experts.
  • statistical methods and / or methods of artificial intelligence in order to first of all obtain correlations between the data, the severity of cardiac insufficiency and the therapeutic success in taking certain measures from a large amount of data from patients suffering from cardiac insufficiency in order to use these correlations in a further step for the prediction and for the determination of recommendations for action (eg calculation of the optimal dosage).
  • the evaluation unit continuously receives sensor data and monitors the tissue water content in the person.
  • critical tissue water content value and / or improvement period and / or normal range are adapted to the course of the disease. If there is no reduction in the tissue water content below the critical tissue water content value within the improvement period, the evaluation unit issues a message or transmits it to another computer that the person should be given a Vla / V2 vasopressin receptor antagonist.
  • the (optimal) dosage and / or the treatment duration can be calculated by the evaluation unit on the basis of the sensor data and possibly on the basis of further patient data. The result of the calculations may be displayed on a screen, stored in a database, transmitted to a separate computer, and / or transmitted to a medication delivery system (dispenser).
  • the donor may be configured to automatically administer the appropriate dosage of the subject over the duration of the treatment, or to spend the appropriate dosage over the duration of the treatment so that the person can take the dosage himself or a doctor or caregiver can administer the dosage of the person is the treatment with the VI a / V2-Vasopressin Receptor antagonist terminates, as shown by the fact that either the end of the specified treatment time is reached or the tissue water content has reached the normal range, the dosage is set to zero.
  • FIG. 1 shows schematically an embodiment of the system according to the invention.
  • FIG. 2 schematically shows a further embodiment of the system according to the invention.
  • FIG. 3 shows schematically a further embodiment of the system according to the invention.
  • FIG. 4 shows schematically an embodiment of the method according to the invention.
  • FIG. 5 schematically shows a further embodiment of the method according to the invention.
  • FIG. 6 shows schematically a further embodiment of the method according to the invention.
  • the system comprises two separate devices, a sensor unit (10) and an evaluation unit (20).
  • the sensor unit (10) comprises a sensor (12) for recording measured values by means of which the tissue water content in the chest region of a person can be determined, a transmission unit (13) with which measured values can be transmitted to the evaluation unit (20) and a control unit (12). 11) for controlling the acquisition of measured values and transmission of measured values.
  • the evaluation unit (20) comprises a receiving unit (24) for receiving measured values from the sensor unit (10) and a dosage determination and / or treatment duration determination unit (25).
  • the evaluation unit (20) further comprises a transmitting unit (23) for transmitting data and a control unit (21) for controlling the reception of measured values via the receiving unit (24), for controlling the transmission of data by means of the transmitting unit (23) and for control the components of the evaluation unit (20) and the data flows and signal flows between these components.
  • the evaluation unit (20) further comprises an input and output unit (26) for controlling the evaluation unit (20) by a user and / or for communication of the evaluation unit (20) with a user.
  • input means for example, a keyboard, a mouse, a microphone, a touch screen and the like into consideration;
  • a screen, a printer, a loudspeaker, a data memory and the like are conceivable as output devices.
  • the embodiment of the system according to the invention shown in FIG. 2 comprises a single device: a combined sensor and evaluation unit (30).
  • the combined sensor and evaluation unit (30) has a sensor (32), a control unit (31), a Dose determination and / or treatment duration determination unit (35) and an input and output unit (36).
  • the combined sensor and evaluation unit (30) is connected via a network (represented by the dashed line) to other computer systems (represented by a cloud 50).
  • FIG. 3 The embodiment of the system according to the invention shown in FIG. 3 comprises two separate devices: a sensor unit (10) and an evaluation unit (20).
  • the sensor unit (10) comprises a sensor (12) for acquiring measured values by means of which the tissue water content in the chest region of a person can be determined, a transmission unit (13) with which measured values can be transmitted to the evaluation unit (20), and a control unit (11) for controlling the acquisition of measured values and transmission of measured values.
  • the evaluation unit (20) comprises a receiving unit (24) for receiving measured values from the sensor unit (10), a dosage determination and / or treatment duration determination unit (25), a control unit (21) and input and output unit (26).
  • the evaluation unit (20) is connected via a network (represented by the dashed line) to other computer systems (represented by a cloud 50), in particular to a database (60).
  • Patient data can be stored in the database.
  • the patient data may have been entered into the database by a physician and / or nursing staff and / or the patient themselves and / or relatives, if necessary via a network.
  • patient data can also be detected automatically by one or more further sensors.
  • the evaluation unit (20) is further connected to a medicament dispenser (70) containing several doses of a Vla / V2 vasopressin receptor antagonist.
  • the evaluation unit (20) may transmit a dosage to the donor (70) so that the donor (70) can administer and / or provide the appropriate dosage.
  • FIG. 4 shows a preferred embodiment of the method according to the invention as a flowchart.
  • a sensor for determining a tissue water content in the region of the thorax of a person is provided.
  • the provided sensor is used to acquire data on the tissue water content in the area of the person's chest.
  • the person suffers from heart failure and undergoes standard therapy.
  • There are at defined times ti, t 2, ... N ⁇ recorded readings that make up the tissue water content can be determined at the respective time points. For every time t; So there is a tissue water content value P (t;).
  • a subsequent third step (300) it is checked whether the respective tissue water content value P (f) is greater than or equal to a critical tissue water content value PC. If the respective tissue water content value P (f) is below the critical tissue water content value PC ("" "), the person responds to the standard therapy and no further measures are required (EOP: end of process). If the respective tissue water content value P (f) is greater than or equal to the critical tissue water content value PC, then it is checked in a subsequent step (400) whether the improvement period has already been exceeded (f> T?). If the recovery period is not yet exceeded ("" "), there is still hope that the standard therapy strikes.
  • treatment of the patient with a VI a / V2 vasopressin receptor antagonist is recommended and / or initiated in a subsequent step (500).
  • the dosage with the Vla / V2 vasopressin receptor antagonist and / or the duration of the treatment can be determined on the basis of the last determined tissue water content value, on the basis of several determined tissue water content values or on the basis of the entire time course of the determined tissue water content values.
  • FIG. 5 shows a further preferred embodiment of the method according to the invention as a flowchart.
  • a sensor for determining a tissue water content in the region of the thorax of a person is provided.
  • the provided sensor is used to acquire data on the tissue water content in the area of the person's chest.
  • the person suffers from heart failure and is treated with a VI a / V2 vasopressin receptor antagonist.
  • a subsequent third step (300) it is checked whether the respective tissue water content value P (f) is already in a normal range or whether it is outside the normal range Normal range is.
  • the normal range can be characterized by a threshold value S, for example. If the tissue water content value is greater than the threshold S ("/ ') then it is outside the normal range and Vla / V2 vasopressin receptor antagonist therapy continues If the respective tissue water content value P (f) is not above the threshold S ("""), Therapy with the VI a / V2 vasopressin receptor antagonist is successful, and in a subsequent step (400) further dosing with the Vla / V2 vasopressin receptor antagonist becomes successful in therapy adapted, for example, it can be reduced or set to "zero".
  • FIG. 6 shows a further preferred embodiment of the method according to the invention as a flowchart.
  • a sensor for determining a tissue water content in the region of the thorax of a person is provided.
  • the provided sensor is used to acquire data on the tissue water content in the area of the person's chest.
  • the person suffers from heart failure and is treated with a VI a / V2 vasopressin receptor antagonist.
  • There are at defined times ti, t 2, ... N ⁇ recorded readings that make up the tissue water content can be determined at the respective time points. For every time t; (i 1, 2, ... N) there is thus a tissue water content value P (f).

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Abstract

La présente invention concerne le traitement de l'insuffisance cardiaque. Un capteur destiné à déterminer la teneur en eau des tissus au niveau du thorax est utilisé par une personne souffrant d'insuffisance cardiaque. Si la teneur en eau des tissus ne revient pas à la normale au bout d'un laps de temps défini avec un traitement par la thérapie standard disponible, un traitement avec un antagoniste des récepteurs de la vasopressine V1a/V2 est recommandé. Le dosage de l'antagoniste des récepteurs de la vasopressine V1a/V2 et la durée du traitement avec cet antagoniste des récepteurs de la vasopressine V1a/V2 peuvent être spécifiés sur la base des données du capteur.
EP19700369.2A 2018-01-16 2019-01-10 Assistance dans le cadre du traitement de l'insuffisance cardiaque Pending EP3740236A1 (fr)

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EP18151760 2018-01-16
PCT/EP2019/050512 WO2019141575A1 (fr) 2018-01-16 2019-01-10 Assistance dans le cadre du traitement de l'insuffisance cardiaque

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Publication number Priority date Publication date Assignee Title
FR2775598A1 (fr) 1998-03-06 1999-09-10 Sanofi Sa Compositions pharmaceutiques contenant en association un antagoniste selectif des recepteurs v1a de l'arginine-vasopressine et un antagoniste selectif des recepteur v2 de l'arginine-vasopressine
ATE326241T1 (de) * 2000-05-03 2006-06-15 Warner Lambert Co Pharmazeutische zusammenzetzung enthaltend furosemid und conivaptan zur behandlung des kongestiven herzversagens
US20020128208A1 (en) 2000-12-15 2002-09-12 Snyder James P. Nonpeptide agonists and antagonists of vasopressin receptors
DE102006024024A1 (de) 2006-05-23 2007-11-29 Bayer Healthcare Aktiengesellschaft Substituierte Arylimidazolone und -triazolone sowie ihre Verwendung
CN101541806A (zh) 2006-09-22 2009-09-23 詹森药业有限公司 用作血管升压素拮抗剂的螺环苯并氮杂
WO2008036759A1 (fr) 2006-09-22 2008-03-27 Janssen Pharmaceutica N.V. Spirobenzazépines utilisées en tant qu'antagonistes de vasopressine
US8271080B2 (en) * 2007-05-23 2012-09-18 Cardiac Pacemakers, Inc. Decongestive therapy titration for heart failure patients using implantable sensor
US20090062730A1 (en) * 2007-09-01 2009-03-05 San Hoon Woo Control of body fluid condition using diuretics, based on biological parameters
WO2009117144A1 (fr) 2008-03-20 2009-09-24 Concert Pharmaceuticals, Inc. Composés benzazépines
EP2352499A1 (fr) 2008-10-10 2011-08-10 Janssen Pharmaceutica, N.V. Thérapie d association comprenant des inhibiteurs de récepteur d angiotensine et antagonistes de récepteur de vasopressine
KR20170081178A (ko) 2014-11-03 2017-07-11 바이엘 파마 악티엔게젤샤프트 히드록시알킬-치환된 페닐트리아졸 유도체 및 그의 용도
US20170245794A1 (en) * 2016-02-29 2017-08-31 Medtronic, Inc. Medical system for seamless therapy adjustment

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