Ignite Creation Date:
2024-05-06 @ 8:37 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02778269
Status:
COMPLETED
Last Update Posted:
2017-04-07
First Post:
2016-05-09
Brief Title:
Predicting Hypoglycaemia and Arrhythmias in the Patient With Diabetes and CKD - Validation Study
Sponsor:
RWTH Aachen University
Organization:
RWTH Aachen University
Study Overview
Official Title:
Predicting Hypoglycaemia and Arrhythmias in the Vulnerable Patient With Diabetes and Chronic Kidney Disease - Validation Study
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HypoArrhythmia
Brief Summary:
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 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 andor 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
In this validation study a 12-lead ECG T-shirt consisting of textile electrodes and a data logging device wich can record long-term 12-lead ECG data will be tested The purpose of the T-shirt is to improve the patients comfort for long-term recordings and to prevent adverse effects of regular ECG electrodes Current systems are limited by the use of ECG electrodes involving disadvantages like severe direct side effects on the skin such as rash and bullous lesions as well as slipping electrodes By the means of the proposed ECG T-shirt those drawbacks will be avoided
In this validation study a 12-lead ECG T-shirt consisting of textile electrodes and a data logging device wich can record long-term 12-lead ECG data will be tested The purpose of the T-shirt is to improve the patients comfort for long-term recordings and to prevent adverse effects of regular ECG electrodes Current systems are limited by the use of ECG electrodes involving disadvantages like severe direct side effects on the skin such as rash and bullous lesions as well as slipping electrodes By the means of the proposed ECG T-shirt those drawbacks will be avoided
Detailed Description:
Patients with diabetes mellitus DM especially those with a long duration of diabetes insulin treatment and chronic kidney disease CKD are vulnerable patients exhibiting a high risk for cardiac arrhythmias and sudden cardiac death SCD Various factors such as the presence of coronary heart disease diabetic cardiomyopathy as well autonomic neuropathy are underlying pathologies associated with the development of potentially fatal arrhythmias in these patients while hypoglycemic events are considered to directly trigger these arrhythmias It has been postulated that severe hypoglycemia may lead to cardiac arrhythmias later summarized as the dead in bed syndrome In addition recent data from large cardiovascular outcome trials in patients with type 2 diabetes suggest that severe hypoglycemia is associated with an increased risk of cardiovascular events and cardiovascular related death Moreover CKD markedly increases the risk for hypoglycemia and even a moderate impairment of kidney function eGFR 45 mlmin is associated with a significant increase in SCD
Various pathophysiological mechanisms may contribute to the increased cardiovascular mortality after hypoglycemia including hypoglycemia-induced release of catecholamines pro-arrhythmogenic ECG alterations as well as inflammatory changes Morphological and functional alterations of the heart occurring in CKD further contribute to these mechanisms So far performed studies were limited by a short duration of glucose and ECG monitoring and by the fact that only 3 lead Holter-ECGs were used thus not allowing the assessment of more sophisticated ECG abnormalities such as QT dispersion T-wave alternans or late potentials Therefore no clear data exist to predict arrhythmias and SCD and its relation to hypoglycemia in patients with diabetes Ideally a SCD risk score could identify and characterize high-risk patients but to date little is known about hypoglycemia-associated ECG markers for the identification of patients at risk for arrhythmias and SCD
In the general population various ECG risk markers for SCD have been identified such as heart rate cardiac rhythm abnormalities atrioventriculare AV block QT length QT dispersion heart-rate variability HRV T-wave alternans late potentials as well as left- LBBB or right-bundle branch block RBBB reviewed in In patients with diabetes hypoglycemia diabetic cardiomyopathy as well as the presence of autonomic neuropathy may lead to such ECG abnormalities Merely sparse data exist on the effect of spontaneous hypoglycemic episodes and changes in ECG parameters with only a small study in patients with type 1 diabetes demonstrating that nocturnal hypoglycemia is associated with a decrease in the low-frequency component of heart rate variability To date more sophisticated markers such as QT dispersion late potentials or T-wave alternans were not examined in a real-life setting most likely because these markers require a 12 lead ECG registration of longer duration
However for the establishment of a risk algorithm for the prediction of hypoglycemia-associated arrhythmias it is mandatory to perform long duration simultaneous glucose monitoring and 12 lead ECG registration to capture these ECG risk markers for SCD
In an actually running project the investigators are evaluating the association of hypoglycemic eventsglucose swings and arrhythmiasECG predictors for SCD a clinical study will be performed in 50 patients with insulin-treated diabetes and moderate to severe CKD These patients receive 7 days continuous glucose and ECG registration and data will be used for the development of the risk assessment model
The current validation study seeks to confirm the risk assessment model developed in collaboration with AICES - Aachen Institute for Advanced Study in Computational Engineering Science and to approve the capacitive ECG registration device obtained in collaboration with Philips Chair for Medical Information Technology at University Clinical Center Aachen UKA To this end 10 patients with insulin-treated diabetes and moderate to severe CKD will be included Seven day glucose monitoring as well as data of capacitive ECG recordings will be generated in this study thus allowing validation and adjustment of the developed medical hardware and the mathematic models The study item is a 12-lead ECG T-shirt consisting of textile electrodes and a data logging device The device can record long-term 12-lead ECG data The purpose of the T-shirt is to improve the patients comfort for long-term recordings and to prevent adverse effects of regular ECG electrodes Current systems are limited by the use of ECG electrodes which are hardly tolerated by the patients because of severe direct side effects on the skin such as rash and bullous lesions These side effects are a result of skin preparation and electrode gel The proposed ECG T-shirt does not need these problematic preparations Another benefit is the fixed placement of the electrodes on the T-shirt In regular 12-lead ECG long-term recordings the electrodes may fall off and the patient needs to reattach them Therefore faulty positioning of the electrodes may occur
Various pathophysiological mechanisms may contribute to the increased cardiovascular mortality after hypoglycemia including hypoglycemia-induced release of catecholamines pro-arrhythmogenic ECG alterations as well as inflammatory changes Morphological and functional alterations of the heart occurring in CKD further contribute to these mechanisms So far performed studies were limited by a short duration of glucose and ECG monitoring and by the fact that only 3 lead Holter-ECGs were used thus not allowing the assessment of more sophisticated ECG abnormalities such as QT dispersion T-wave alternans or late potentials Therefore no clear data exist to predict arrhythmias and SCD and its relation to hypoglycemia in patients with diabetes Ideally a SCD risk score could identify and characterize high-risk patients but to date little is known about hypoglycemia-associated ECG markers for the identification of patients at risk for arrhythmias and SCD
In the general population various ECG risk markers for SCD have been identified such as heart rate cardiac rhythm abnormalities atrioventriculare AV block QT length QT dispersion heart-rate variability HRV T-wave alternans late potentials as well as left- LBBB or right-bundle branch block RBBB reviewed in In patients with diabetes hypoglycemia diabetic cardiomyopathy as well as the presence of autonomic neuropathy may lead to such ECG abnormalities Merely sparse data exist on the effect of spontaneous hypoglycemic episodes and changes in ECG parameters with only a small study in patients with type 1 diabetes demonstrating that nocturnal hypoglycemia is associated with a decrease in the low-frequency component of heart rate variability To date more sophisticated markers such as QT dispersion late potentials or T-wave alternans were not examined in a real-life setting most likely because these markers require a 12 lead ECG registration of longer duration
However for the establishment of a risk algorithm for the prediction of hypoglycemia-associated arrhythmias it is mandatory to perform long duration simultaneous glucose monitoring and 12 lead ECG registration to capture these ECG risk markers for SCD
In an actually running project the investigators are evaluating the association of hypoglycemic eventsglucose swings and arrhythmiasECG predictors for SCD a clinical study will be performed in 50 patients with insulin-treated diabetes and moderate to severe CKD These patients receive 7 days continuous glucose and ECG registration and data will be used for the development of the risk assessment model
The current validation study seeks to confirm the risk assessment model developed in collaboration with AICES - Aachen Institute for Advanced Study in Computational Engineering Science and to approve the capacitive ECG registration device obtained in collaboration with Philips Chair for Medical Information Technology at University Clinical Center Aachen UKA To this end 10 patients with insulin-treated diabetes and moderate to severe CKD will be included Seven day glucose monitoring as well as data of capacitive ECG recordings will be generated in this study thus allowing validation and adjustment of the developed medical hardware and the mathematic models The study item is a 12-lead ECG T-shirt consisting of textile electrodes and a data logging device The device can record long-term 12-lead ECG data The purpose of the T-shirt is to improve the patients comfort for long-term recordings and to prevent adverse effects of regular ECG electrodes Current systems are limited by the use of ECG electrodes which are hardly tolerated by the patients because of severe direct side effects on the skin such as rash and bullous lesions These side effects are a result of skin preparation and electrode gel The proposed ECG T-shirt does not need these problematic preparations Another benefit is the fixed placement of the electrodes on the T-shirt In regular 12-lead ECG long-term recordings the electrodes may fall off and the patient needs to reattach them Therefore faulty positioning of the electrodes may occur
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None