Home Monitoring in Cardiac Resynchronisation Therapy (HomeCARE)

This study has been completed.
Sponsor:
Information provided by:
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT00376116
First received: September 13, 2006
Last updated: November 14, 2008
Last verified: November 2008
  Purpose

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.


Condition Intervention
Heart Failure, Congestive
Device: Cardiac resynchronisation therapy
Device: Implantable cardioverter-defibrillator

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Home CARE - Home Monitoring in CArdiac REsynchronisation Therapy

Resource links provided by NLM:


Further study details as provided by Biotronik SE & Co. KG:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 513
Study Start Date: March 2005
Study Completion Date: November 2008
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376116

  Show 82 Study Locations
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
Principal Investigator: Stefan Sack, Associate Prof. Dr. Division of Cardiology, University of Essen, Germany
Principal Investigator: Vincent Paul, MD Cardiology Department, St. Peter's Hospital, Chertsey Surrey, United Kingdom
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00376116     History of Changes
Other Study ID Numbers: TA056
Study First Received: September 13, 2006
Last Updated: November 14, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Biotronik SE & Co. KG:
Implantable cardioverter-defibrillator
Pacemaker
Cardiac resynchronisation therapy
Heart failure
Predictor
Mortality
Rehospitalization
Telemedicine
Home Monitoring

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014