Home Monitoring in Cardiac Resynchronisation Therapy
- Conditions
- Heart Failure, Congestive
- Registration Number
- NCT00376116
- Lead Sponsor
- Biotronik SE & Co. KG
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 513
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Predictive power of HFM-parameters regarding cardiovascular-based death or rehospitalisation (overnight stay) 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)
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (80)
LKH-Universitätsklinikum Graz
🇦🇹Graz, Austria
Medizinische Universität Wien
🇦🇹Wien, Austria
Fakultni nemocnice u Svety Anny
🇨🇿Brno, Czech Republic
IKEM
🇨🇿Praha, Czech Republic
Petr Neuzil M.D., Ph.D.
🇨🇿Praha, Czech Republic
Centre Hospitalier Universitaire d'Angers
🇫🇷Angers, France
Hôpital Cardiologique du Haut Lévêque
🇫🇷Bordeaux, France
CHU de Lyon - Hôpital Louis Pradel
🇫🇷Lyon, France
Groupe Hospitalier de la Timone
🇫🇷Marseille, France
CHRU Hôpital de Villeneuve, Cardiologie A
🇫🇷Montpellier, France
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