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Completed

NCT Number: NCT00376116

Home Monitoring in Cardiac Resynchronisation Therapy

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.

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Key information

Conditions

Heart Failure, Congestive Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LKH-Universitätsklinikum Graz, Graz, Austria

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac resynchronisation therapy

Device

Implantable Cardioverter-defibrillator

Device

Primary outcomes

  1. 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)

  2. Predictive power of HFM-parameters regarding cardiovascular-based death or rehospitalisation (overnight stay)

Secondary outcomes

  1. Effectiveness of HM (within sub-study)

  2. Correlation of HM-values with the clinical status

  3. Evaluation of the predictive power of HM parameters not implemented in the HFM and of parameters not transmitted by HM (diagnostic memory of device)

  4. Sensitivity of HM-parameter regarding change of drug therapy

  5. Incidence and reasons for HM-based interventions

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Official study title

Home CARE - Home Monitoring in CArdiac REsynchronisation Therapy

Acronym: HomeCARE

Important dates

Study start
2005
Study completion
2008
First posted
Sep 14, 2006
Registry last updated
Nov 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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