RU2336811C1 - Method for diagnostics of cardiovascular autonomous neuropathy of diabetes and suffering chronic cardiac insufficiency patients - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: electrocardiogram is registered within 5 minutes at the patient who is at rest and variability of cardiac rhythm is analysed. At the analysis of variability of cardiac rhythm standard deviation of intervals between normal sinoatrial cardiocycles (SDNN) is defined. At SDNN value less than 33 ms diabetic cardiovascular autonomous neuropathy is diagnosed. This way expands the arsenal of means allowing to diagnose cardiovascular autonomous neuropathy of diabetes patients at presence of chronic cardiac insufficiency.

EFFECT: expansion of arsenal of means allowing to diagnose cardiovascular autonomous neuropathy of diabetes patients at presence of chronic cardiac insufficiency.

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Description

The present invention relates to medicine, namely to therapy, cardiology and endocrinology, and can be used to diagnose cardiovascular autonomic neuropathy in patients with diabetes mellitus suffering from chronic heart failure.

The combination of type 2 diabetes mellitus (T2DM) and chronic heart failure (CHF) is a common syndrome. Epidemiological studies indicate that from 15 to 26% of patients with circulatory failure suffer from T2DM [1]. About 12% of patients with type 2 diabetes have signs of heart failure [2]. Cardiovascular Autonomic Neuropathy (CAS) is considered a common complication of T2DM. Data on the frequency of detection of CAS in various studies is variable and ranges from 34 to 90% [3, 4]. Identification of CAS requires appropriate medical measures. Existing methods for diagnosing CAS are applicable in cases where the patient has CHF. The proposed research method allows you to diagnose CAS in patients with type 2 diabetes suffering from heart failure.

Traditionally, for the diagnosis of CAS, cardiovascular tests (CVPs) proposed by D. Ewing (1975) and approved at the conference on diabetic neuropathy (San Antonio, 1988) [5, 6] are used. However, the condition for the use of these tests is the absence of signs of heart failure in patients [7, 8]. Arterial hypertension, coronary heart disease, cardiotropic drugs may affect the results of CVP [9].

In recent years, for the diagnosis of CAS in patients with diabetes, a study of heart rate variability (HRV) has been used. This method includes recording an electrocardiogram (at rest for 5 minutes or for 24 hours with daily monitoring), followed by the assessment of HRV by the methods of time analysis and spectral analysis. Signs of the presence of CAS are: power reduction in all frequency ranges, the absence of an increase in the low-frequency component upon rising, an abnormally reduced total spectrum power [10]. But such changes in the described tests are also characteristic of patients with heart failure [11, 12, 13].

Thus, a drawback of existing methods is the inability to diagnose CAS in patients with diabetes if they have heart failure.

The task of the invention is to enable the diagnosis of cardiovascular autonomic neuropathy in patients with type 2 diabetes, suffering from chronic heart failure.

The objective of the method for the diagnosis of cardiovascular autonomic neuropathy in patients with diabetes mellitus, which includes recording an electrocardiogram (ECG) at rest for 5 minutes, followed by an analysis of heart rate variability, is achieved in that if a patient with diabetes has chronic heart failure in the analysis of variability heart rate determine the standard deviation of the intervals between normal sinus cardiocycles (SDNN) and with a SDNN value of less than 33 ms I diagnose diabetic cardiovascular autonomic neuropathy.

The proposed method is as follows. The study is carried out on an empty stomach or 2 hours after a meal. Immediately before the test, the patient rests lying on his back for 15 minutes. In the room where the study is conducted, there should be a calm environment: the absence of noise, bright light and other annoying factors. During the test, the patient is lying on his back with his eyes closed, not talking.

Electrodes are placed on the limbs and the ECG (3 standard leads) is recorded within 5 minutes using the Polyspectrum-Rhythm device, Neurosoft (Russia). The calculation of the SDNN indicator is carried out on a personal computer using the PolySecr program. If the SDNN value is less than 33 ms, diabetic cardiovascular autonomic neuropathy is diagnosed.

To substantiate the proposed method, the following study. 160 people were examined. The first group (group 1) consisted of 78 patients with type 2 diabetes, suffering from heart failure. The second group (group 2) consisted of 45 patients with heart failure without impaired carbohydrate metabolism. In addition, 17 people without carbohydrate metabolism and cardiovascular diseases (group 3), and 20 patients with type 2 diabetes without heart failure (group 4) were examined.

The groups did not differ in age and gender of the included patients. Groups 1 and 2 did not have significant differences in the severity and genesis of heart failure. All patients of groups 1 and 2 received standard therapy for heart failure (angiotensin-converting enzyme inhibitors, β-blockers). The study did not include patients with myocardial infarction, kidney damage, atrial fibrillation, and persons older than 70 years. A history was collected in all patients, and a physical examination was performed. Assessment of the severity of CHF was carried out on the basis of the clinical condition assessment scale (SHOKS according to V. Mareev, 2000).

All patients underwent CVP, and the criteria proposed by D.Ewing [5] in the modification of Vinik A.I. were applied in evaluating their results. [fourteen]. The study of heart rate variability by the method of time and spectral analysis was carried out on the apparatus "Polyspectrum-Rhythm", the company "Neurosoft" (Russia). The following indicators were calculated: TP (total power of the spectrum), LF (spectral power of the low-frequency component of the spectrum), HF (spectral power of the high-frequency component of the spectrum), SDNN (standard deviation of the intervals between normal sinus cardiocycles), CV (coefficient of variation of a number of intervals between normal sinus cardiocycles )

Persons without cardiovascular disease, in contrast to patients with heart failure, had significantly better indicators of CVP and HRV (see table 1).

Table 1
Indicators of cardiovascular tests and heart rate variability in patients with heart failure and patients without cardiovascular diseases, the significance of the differences was calculated by the Mann-Whitney method (SBP - systolic blood pressure, DBP - diastolic blood pressure). Indicator Group 1 + group 2 (patients with heart failure +) N = 123 (median and interquartile range) Group 3 (patients with CHF-; SD2-) N = 17 (median and interquartile range) R Respiratory rate 1.09 (1.06-1.16) 1.14 (1.1-1.21) 0.008 Valsalva coefficient 1.11 (1.06-1.24) 1.31 (1.2-1.67) <0.001 Coefficient 30/15 1.08 (1.05-1.16) 1.17 (1.13-1.28) <0.001 Decrease in SBP in an orthostatic test, mmHg 10 (-5-20) 0 (0-10) 0.144 The increase in DBP in the sample with an isometric contraction, mmHg 5 (0-10) 15 (15-20) <0.001 TP ms2 1064 (411-1905) 2733 (1396-3499) <0.001 Lf ms2 211 (76-512) 529 (371-1061) <0.001 Hf ms2 166 (55-550) 638 (158-1115) 0.007 SDNN, ms 29 (20-44) 40 (35-58) 0.008 CV,% 3.15 (2.09-4.6) 4.5 (4.09-6.8) <0.001

In both groups of patients with heart failure (groups 1 and 2), pathological changes in the results of both CVP and HRV were revealed. However, the KVP indices, with the exception of the test with isometric reduction, did not differ in both groups. At the same time, when assessing HRV in patients of groups 1 and 2, a significant and significant difference in indicators was revealed (see table 2). This fact can be explained by the presence of CAN in some patients of the 1st group.

table 2
Indicators of cardiovascular tests and heart rate variability in heart failure with type 2 diabetes and in patients with heart failure without impaired carbohydrate metabolism, the significance of the differences was calculated by the Mann-Whitney method. Indicator Group 1 (CHF +; T2 + 2) N = 78 (median and interquartile range) Group 2 (CHF +; SD2-) N = 45 (median and interquartile range) R Respiratory rate 1.07 (1.05-1.15) 1.09 (1.07-1.19) 0.18 Valsalva coefficient 1.11 (1.06-1.22) 1.13 (1.06-1.3) 0.97 Coefficient 30/15 1.09 (1.06-1.2) 1.15 (1.07-1.31) 0.9 Decrease in SBP in an orthostatic test, mmHg 10 (-10-20) 10 (0-20) 0.28 The increase in DBP in the sample with an isometric contraction, mmHg 0 (0-10) 10 (10-15) <0.001 TP ms2 894 (394-1744) 1453 (481-3146) <0.001 Lf ms2 167 (75-382) 355 (87-760) 0.005 Hf ms2 155 (40-413) 213 (71-1163) 0.01 SDNN, ms 26 (18-40) 37 (22-54) <0.001 CV,% 2.8 (1.94-4.29) 3.85 (2.69-4.98) 0.001

In the group of patients with type 2 diabetes mellitus suffering from heart failure (group 1), a cluster analysis was carried out according to the results of tests characterizing the severity of heart failure (SHOC), and HRV indices. 2 clusters were identified in which the HRV indices were significantly different, and the severity of heart failure did not have significant differences. So, in the 1st cluster (26 patients), the median SDNN was 44.5 ms (interquartile range 40-50, minimum 33 ms, maximum 78 ms), in the 2nd cluster (52 patients) the median SDNN was 20 ms (interquartile interval 14-26, minimum 10 ms, maximum 32 ms) at p <0.001, the significance of the differences was calculated by the Mann-Whitney method (see drawing).

The following is a description of the illustration. The drawing shows a graph depicting the results of a cluster analysis in a group of patients with T2DM suffering from heart failure.

Shocks medians in both clusters were 4 points. Thus, the differences between the clusters are not associated with the severity of heart failure, but are probably determined by the presence of cardiovascular autonomic neuropathy in patients assigned to the 2nd cluster. A SDNN level of less than 33 ms is proposed as a criterion for the diagnosis of CAN in patients with type 2 diabetes and heart failure.

To determine the qualitative characteristics of the proposed criterion, 20 patients with type 2 diabetes without signs of heart failure were examined (group 4). The criteria of Ewing D.J., Vinik A.I. were used as the “gold standard” for the diagnosis of CAS. [fourteen]. The results are presented in table 3. According to the table, the following characteristics of the proposed criterion were calculated: sensitivity - 70%, specificity - 90%, predictive value of a positive result - 88%, predictive value of a negative result - 75%.

Table 3
The relationship between the results of cardiovascular tests and the level of SDNN, the significance of differences was calculated using the chi-square Pearson criterion (p = 0.006). CAN + CAN Patients with abnormal results of CVP Patients with normal CVP results CAN test criterion (SDNN <33 ms) SDNN <33 ms, person 7 (true positive) 1 (false positive) SDNN> 33 ms, person 3 (false negative) 9 (true negative)

Thus, for the diagnosis of cardiovascular autonomic neuropathy in patients with type 2 diabetes mellitus suffering from chronic heart failure, an analysis of heart rate variability with a 5-minute ECG recording is necessary. SDNN <33 ms indicates the presence of neuropathy. The proposed diagnostic method is characterized by high specificity and high prognostic value of a positive result.

Examples of specific applications of the proposed diagnostic method are given in the form of extracts from medical histories.

Example 1. Patient C., 53 years old.

Diagnosis: coronary heart disease, angina pectoris II, post-infarction cardiosclerosis, chronic heart failure II (NYHA). Type 2 diabetes mellitus, compensated.

A coronary history of about 3 years in the form of angina pectoris, 1 year ago suffered a posterior HeQ myocardial infarction, has signs of chronic heart failure of the II functional class. He is constantly receiving treatment with angiotensin-converting enzyme inhibitors, β-blockers. Suffers from type 2 diabetes for 1 year, receives treatment with gliclazide.

The study of heart rate variability on the apparatus "Polyspectrum-Rhythm": SDNN - 14 ms. Conclusion: the test for the presence of CAS by the proposed method is positive, this patient has a cardiovascular form of diabetic autonomic neuropathy. In order to treat this complication of diabetes mellitus, lipoic acid preparations were added to the treatment.

Example 2. Patient K., 55 years old.

Diagnosis: coronary heart disease, angina pectoris II, chronic heart failure III (no NYHA). Hypertonic disease. Type 2 diabetes mellitus, compensated.

A coronary history of 5 years, about 10 years, noted an increase in blood pressure. Has signs of chronic heart failure III functional class. He suffers from type 2 diabetes mellitus for 10 years, he has been using insulin for the last 2 years. He is constantly receiving treatment with angiotensin-converting enzyme inhibitors, β-blockers.

The study of heart rate variability on the apparatus "Polyspectrum-Rhythm": SDNN - 14 ms. Conclusion: the test for the presence of CAS by the proposed method is positive, this patient has a cardiovascular form of diabetic autonomic neuropathy. In order to treat this complication of diabetes mellitus, lipoic acid preparations were added to the treatment.

Example 3. Patient X., 69 years old.

Diagnosis: coronary heart disease, angina pectoris II, chronic heart failure III (NYHA). Hypertonic disease. Type 2 diabetes mellitus, compensated.

A coronary history of about 7 years in the form of angina pectoris, hypertension for more than 10 years, no heart attacks. Diabetes mellitus for 20 years, the last 5 years injected insulin. He is constantly receiving treatment with angiotensin-converting enzyme inhibitors, β-blockers. There are no symptoms and objective signs of peripheral diabetic neuropathy.

The study of heart rate variability on the apparatus "Polyspectrum-Rhythm": SDNN - 51 ms. Conclusion: the test for the presence of CAP according to the proposed method is negative, in this patient there is no cardiovascular form of diabetic autonomic neuropathy.

Example 4. Patient K., 55 years old.

Diagnosis: coronary heart disease, angina pectoris II, post-infarction cardiosclerosis, chronic heart failure II (NYHA). Hypertonic disease. Type 2 diabetes mellitus, first detected, compensated.

Hypertension for 6 years, the last 3 years has been diagnosed with coronary heart disease, β-blockers, nitrates, angiotensin-converting enzyme inhibitors have been prescribed. The age of myocardial infarction is unknown (on the ECG cicatricial changes were found on the front wall of the left ventricle). The clinic revealed diabetes mellitus, prescribed oral hypoglycemic drugs. There are no symptoms and objective signs of peripheral diabetic neuropathy.

The study of heart rate variability on the apparatus Polispectr-Rhythm ": SDNN - 51 ms. Conclusion: the test for the presence of CAP according to the proposed method is negative, in this patient there is no cardiovascular form of diabetic autonomic neuropathy.

Literature

1. Bauters C., Lamblin N., Me Fadden E.P., Van Belle E., 1 Millaire A., Groote P. Influence of diabetes mellitus on heart failure risk and outcome. Cardiovasc Diabetol. 2003; 2 (1): 1

2. Nichols G.A., Hillier T.A., Erbey J.R., Brown J.B. Congestive Heart Failure in Type 2 Diabetes. Prevalence, incidence, and risk factors. Diabetes Care 2001; 24: 1614-1619.

3. Ziegler D, Gries FA, Spuler M, Lessmann F, Diabetic Cardiovascular Autonomic Neuropathy Multicenter Study Group: The epidemiology of diabetic neuropathy. J Diabetes Complications 1992; 6: 49-57.

4. Parishioners V.M. Damage to the nervous system in diabetes. M .: Medicine, 1991, p. 295.

5. Ewing D.J., Campbell I.W., Murray H., Neilson J.M., Clarke B.F. Immediate heart-rate response to standing: simple test for autonomic neuropathy in diabetes. BMJ 1978; 1: 145-147.

6. American Diabetes Association and American Academy of Neurology: Report and recommendations of the San Antonio Conference on diabetic neuropathy (Consensus Statement). Diabetes 1988; 37: 1000-1004.

7. Vinik A.I., Maser R.E., Mitchell B.D., Freeman R. Diabetic Autonomic Neuropathy. Diabetes Care 2003; 26: 1553-1579.

8. Cooper I.A., Demin A.A., Koroleva E.A. Diabetic autonomic neuropathy. Novosibirsk: NSTU Publishing House, 2006, 32-33.

9. Mikhailov V.M. Heart rate variability: practical experience with the method. Ed. the second is a reslave. and add. Ivanovo: Ivanovo State Medical Academy, 2002, 54-55.

10. Howorka K, Pumpria J, Schabmann A: Optimal parameters for short-term heart rate spectrogram for routine evaluation of diabetic cardiovascular autonomic neuropathy. J Auton Nerv Syst 1998; 69: 164-172.

11. Nolan J., Batin P. D., Andrews R Prospective study of heart rate variability and mortality in chronic heart failure. Circulation 1998; 98: 1510-1516.

12. Bonaduce D., Petretta M., Marciano F. Independent and incremental prognostic value of heart rate variability in patients with heart failure. Amer. Heart J. 1999; 8: 138-145.

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14. Vinik AI, Erbas T: Recognizing and treating diabetic autonomic neuropathy. Cleve Clin J Med 2001; 68: 928-944.

List of abbreviations

HRV - heart rate variability

DBP - diastolic blood pressure

CAS - Cardiovascular Autonomic Neuropathy

KVP - cardiovascular tests

ms - millisecond

GARDEN - systolic blood pressure

T2DM - type 2 diabetes mellitus

CHF - chronic heart failure

SHOKS - clinical condition assessment scale

ECG - electrocardiogram

CV - coefficient of variation of a number of intervals between normal sinus cardiocycles

HF - spectral power of the high-frequency component of the spectrum

LF - spectral power of the low-frequency component of the spectrum

NYHA - New York Heart Association

SDNN - standard deviation of the intervals between normal sinus cardiocycles

TP - total power spectrum

Claims (1)

A method for diagnosing cardiovascular autonomic neuropathy in patients with diabetes mellitus by recording an electrocardiogram at rest for 5 min followed by an analysis of heart rate variability, characterized in that in the case of a patient with diabetes mellitus with chronic heart failure, a standard deviation of the intervals between the heart rhythm is determined normal sinus cardiocycles (SDNN), and with a SDNN value of less than 33 ms, a diabetic cardiovascular is diagnosed autonomic neuropathy.

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