Home Monitoring in Cardiac Resynchronisation Therapy

Study Overview
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Brief Summary
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In spite of success in the management of heart failure, repetitive rehospitalisation and high mortality rate remain a serious problem. Recent studies, especially the COMPANION trial, have demonstrated that cardiac resynchronisation therapy (CRT) reduces mortality and rehospitalisation in heart failure patients. There is also evidence that telemonitoring of heart failure patients potentially reduces both mortality and morbidity. Recently, a Home Monitoring (HM) function has been integrated into BIOTRONIK CRT-defibrillators and CRT-pacemakers with a view of harnessing the powerful combination of CRT with close remote monitoring of heart failure patients. It is possible now to transmit predefined parameters on a daily basis from the implanted devices to a web-based platform accessible by patients' physicians. Our study evaluates clinical usefulness of Biotronik HM function in CRT-defibrillators and CRT-pacemakers.

Detailed Description
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Clinical investigations identified potential predictors for mortality and rehospitalisation events in heart failure patients. A selection of these predictors primarily composes the Heart Failure Monitor (HFM), which is implemented in Biotronik implantable cardioverter defibrillators (ICDs) capable of delivering cardiac resynchronisation therapy (CRT) as well as in CRT-pacemakers. HFM and other parameters are transmitted to the attending physician via Home Monitoring (HM) function integrated in the implanted devices. In the future, a HFM with high predictive power may play an important role as part of a strategy of delivering effective health care for heart failure patients with an indication for CRT. Our included patients implanted with CRT devices STRATOS LV-T (CRT-pacemaker), KRONOS LV-T, or Lumax HF-T (CRT-ICD). Pre-discharge protocol comprised standard device follow-up, activation of the HM-function, and assessment of complications and cardiovascular events. At follow-up controls 1, 3, 6, 9, and 12 months after implantation, standard device follow-up was performed and complications and cardiovascular events were assessed. At enrollment, 6 and 12 months postoperative and in case of a rehospitalisation, the following parameters are documented: Echocardiographic parameters Quality of Life (Minnesota) ECG-parameters, NYHA-classification Blood pressure, body weight BNP / NT-pro BNP (optional) 6 minute walk test (optional) At 1, 3 and 9 months postoperative: ECG-parameters, NYHA-classification Blood pressure, body weight BNP / NT-pro BNP (optional) 6 minute walk test (optional) Further documentation: Change of drug treatment Any cardiovascular event and therapeutic intervention Heart failure related symptoms by means of patient diary

Official Title
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Home CARE - Home Monitoring in CArdiac REsynchronisation Therapy

Conditions
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Heart Failure, Congestive

Intervention / Treatment
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* Device: Cardiac resynchronisation therapy
* Device: Implantable cardioverter-defibrillator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written patient informed consent Indication for CRT (biventricular or bifocal) Sufficient GSM-network coverage in the patient's area Stable residence during follow-up (anticipated) at least 1 documented hospitalisation due to heart failure within 12 months before enrolment Exclusion Criteria: Permanent atrial fibrillation Myocardial infarction or instable Angina Pectoris within the last 3 months Planned cardiac interventions within the next 3 months (e.g. PTCA, CABG, HTX) Acute myocarditis Life expectancy under 6 months Pregnant or breast-feeding woman Participation in another clinical study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cardiac resynchronisation therapy|nan|
|Device: Implantable cardioverter-defibrillator|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of (single or combined) HFM-parameters (onset of arrhythmias, duration of physical activity, mean heart rate at rest and over 24h, %CRT, lead impedance) |  |  | 
| Predictive power of HFM-parameters regarding cardiovascular-based death or rehospitalisation (overnight stay) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of HM (within sub-study) |  |  | 
| Correlation of HM-values with the clinical status |  |  | 
| Evaluation of the predictive power of HM parameters not implemented in the HFM and of parameters not transmitted by HM (diagnostic memory of device) |  |  | 
| Sensitivity of HM-parameter regarding change of drug therapy |  |  | 
| Incidence and reasons for HM-based interventions |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implantable cardioverter-defibrillator, Pacemaker, Cardiac resynchronisation therapy, Heart failure, Predictor, Mortality, Rehospitalization, Telemedicine, Home Monitoring