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Home Monitoring in Cardiac Resynchronisation Therapy

Home CARE - Home Monitoring in CArdiac REsynchronisation Therapy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00376116
Acronym
HomeCARE
Enrollment
513
Registered
2006-09-14
Start date
2005-03-31
Completion date
2008-11-30
Last updated
2008-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Congestive

Keywords

Implantable cardioverter-defibrillator, Pacemaker, Cardiac resynchronisation therapy, Heart failure, Predictor, Mortality, Rehospitalization, Telemedicine, Home Monitoring

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

Interventions

Sponsors

Biotronik SE & Co. KG
Lead SponsorINDUSTRY

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

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

Countries

Austria, Czechia, France, Germany, Israel, Italy, Latvia, Netherlands, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026