Electrocardiography Clinical Trial
— HypoArrhythOfficial title:
Predicting Hypoglycaemia and Arrhythmias in the Vulnerable Patient With Diabetes and Chronic Kidney Disease
Verified date | May 2016 |
Source | RWTH Aachen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Committee |
Study type | Interventional |
Patients with insulin-dependent diabetes mellitus (DM) and chronic kidney disease (CKD) exhibit an excessive risk for cardiac arrhythmias, in particular sudden cardiac death (SCD). Hypoglycemia is a frequent problem in insulin-treated patients, especially in those with CKD, and various studies have shown that hypoglycemic episodes are strong predictors of cardiovascular mortality in both type 1 and type 2 diabetic patients. Experimental data and small clinical studies link hypoglycemia with ECG changes and SCD, but little is known about the direct association of hypoglycemic events and/or rapid swings in blood glucose with arrhythmias in this high risk population. Ideally, an algorithm should help to identify patients at risk for hypoglycemia-associated arrhythmias and SCD, but hitherto systematic analyses of blood glucose values and 12-channel ECGs are lacking in these patients.
Status | Completed |
Enrollment | 62 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Insulin-treated diabetes mellitus (type 1 or 2) 2. CKD with eGFR < 40 ml/min (determined using the MDRD formula) 3. Stable anti-diabetic and cardiac medication prior to inclusion 4. Male or female aged > 18 years 5. Written informed consent prior to study participation Exclusion Criteria: 1. Pregnancy or women without sufficient contraception, adapted specifically to amenorrhoic hemodialysis patients 2. Life expectancy below 6 months 3. Participation in another clinical trial within the previous 2 months 4. History of any other illness, which, in the opinion of the investigator, might pose an unacceptable risk when administering study medication 5. Any current or past medical condition and/or required medication to treat a condition that could affect the evaluation of the study 6. Alcohol or drug abuse 7. Patient has been committed to an institution by legal or regulatory order 8. Expected non-compliance 9. Patients unwilling or unable to give informed consent, or with limited ability to comply with instructions for this study 10. Participation in a parallel interventional clinical trial |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Germany | Medizinische Klinik I | Aachen | North Rhine Westphalia |
Lead Sponsor | Collaborator |
---|---|
RWTH Aachen University |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | heart rate | Changes of ECG parameters during 7 days long term ECG | not a single event or change of the parameter will be assessed after 18 months patterns of this parameter during a 7 days long-term ECG will screened for potential correlation with hypoglycaemic events | No |
Primary | cardiac rhythm abnormalities | Changes of ECG parameters during 7 days long term ECG | not a single event or change of the parameter will be assessed after 18 months patterns of this parameter during a 7 days long-term ECG will screened for potential correlation with hypoglycaemic events | No |
Primary | AV block | Changes of ECG parameters during 7 days long term ECG | not a single event or change of the parameter will be assessed after 18 months patterns of this parameter during a 7 days long-term ECG will screened for potential correlation with hypoglycaemic events | No |
Primary | QT length | Changes of ECG parameters during 7 days long term ECG | not a single event or change of the parameter will be assessed after 18 months patterns of this parameter during a 7 days long-term ECG will screened for potential correlation with hypoglycaemic events | No |
Primary | QT dispersion | Changes of ECG parameters during 7 days long term ECG | not a single event or change of the parameter will be assessed after 18 months patterns of this parameter during a 7 days long-term ECG will screened for potential correlation with hypoglycaemic events | No |
Primary | heart-rate variability | Changes of ECG parameters during 7 days long term ECG | not a single event or change of the parameter will be assessed after 18 months patterns of this parameter during a 7 days long-term ECG will screened for potential correlation with hypoglycaemic events | No |
Primary | T-wave alternans | Changes of ECG parameters during 7 days long term ECG | not a single event or change of the parameter will be assessed after 18 months patterns of this parameter during a 7 days long-term ECG will screened for potential correlation with hypoglycaemic events | No |
Primary | late potentials | Changes of ECG parameters during 7 days long term ECG | not a single event or change of the parameter will be assessed after 18 months patterns of this parameter during a 7 days long-term ECG will screened for potential correlation with hypoglycaemic events | No |
Primary | left or right bündle branch blocks | Changes of ECG parameters during 7 days long term ECG | not a single event or change of the parameter will be assessed after 18 months patterns of this parameter during a 7 days long-term ECG will screened for potential correlation with hypoglycaemic events | No |
Primary | Glucose Levels < 65 mg/dl | Changes of ECG parameters during 7 days long term ECG | not a single event or change of the parameter will be assessed after 18 months patterns of this parameter during a 7 days long-term ECG will screened for potential correlation with hypoglycaemic events | No |
Secondary | Association anf temporal coincidence of glycemic variability as assessed by changes in glucose excursion as well as mean amplitude of glycemic excursion (MAGE) | occurence of clinically relevant hypoglycemia occurence of symptomatic hypotension occurence of hypertensive urgency & emergency |
18 months | No |
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