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Home Monitoring in Cardiac Resynchronisation Therapy (HomeCARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00376116
Recruitment Status : Completed
First Posted : September 14, 2006
Last Update Posted : November 17, 2008
Sponsor:
Information provided by:
Biotronik SE & Co. KG

Study Description
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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.

Condition or disease Intervention/treatment
Heart Failure, Congestive Device: Cardiac resynchronisation therapy Device: Implantable cardioverter-defibrillator

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
Study Design
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Study Type : Observational
Actual Enrollment : 513 participants
Time Perspective: Prospective
Official Title: Home CARE - Home Monitoring in CArdiac REsynchronisation Therapy
Study Start Date : March 2005
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376116


Locations
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Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
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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
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00376116    
Other Study ID Numbers: TA056
First Posted: September 14, 2006    Key Record Dates
Last Update Posted: November 17, 2008
Last Verified: November 2008
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:
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Heart Failure
Heart Diseases
Cardiovascular Diseases