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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Heart Failure, Congestive | Device: Cardiac resynchronisation therapy Device: Implantable cardioverter-defibrillator |
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 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 |

- 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)
- 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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

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

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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Implantable cardioverter-defibrillator Pacemaker Cardiac resynchronisation therapy Heart failure Predictor |
Mortality Rehospitalization Telemedicine Home Monitoring |
Heart Failure Heart Diseases Cardiovascular Diseases |