Influence of Home Monitoring on the Clinical Status of Heart Failure Patients With an Impaired Left Ventricular Function (IN-TIME)
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| ClinicalTrials.gov Identifier: NCT00538356 |
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Recruitment Status :
Completed
First Posted : October 2, 2007
Last Update Posted : December 23, 2014
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Re-hospitalizations or deaths by worsening heart failure are often preceded by distinct trends of clinical parameters such as atrial or ventricular arrhythmia, activity, heart rate variability, or ventricular ectopy. The Home Monitoring™ capability offered by BIOTRONIK active implants has the potential to detect some of these trends early and thus to offer the possibility to intervene in time for prevention of fatal worsening of heart failure.
To investigate the predictive value of Home Monitoring parameters, patients with symptomatic heart failure and reduced ejection fraction receiving an implantable cardioverter-defibrillator (ICD) or an ICD in combination with cardiac resynchronization therapy (CRT-D) will be randomized between prospective patient management by Home Monitoring analysis or standard care. The influence of Home Monitoring on the clinical status of heart failure patients will be assessed.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ventricular Fibrillation Ventricular Tachycardia Congestive Heart Failure | Device: ICD or CRT-D with Home Monitoring feature deactivated Device: ICD or CRT-D with Home Monitoring feature activated | Phase 4 |
Hospital admissions or deaths by worsening heart failure are often preceded by distinct trends of clinical parameters such as heart rhythm disturbances, daily physical activity of a patient, or mean heart rates.
The Home Monitoring™ capability offered by many BIOTRONIK implants has the potential to detect some of these trends early. During Home Monitoring surveillance, medical and technical data from an ICD or CRT device are sent to a modified mobile phone, the so-called Cardio Messenger. This device transmits the data via a mobile phone network to the BIOTRONIK service center. There, the data are put into an easily accessible form and can then be viewed by the physician online via the internet on a secure website. Additionally, the occurrence of heart rhythm disturbances or device problems will be transmitted by fax, SMS or email.
This unique system allows the attending physician to monitor each patient very closely and to react early enough to prevent worsening of heart failure at an early stage, to optimize therapy, and to secure the correct functioning of the implant.
The goal of IN-TIME is thus to analyze the impact of a regular Home Monitoring evaluation on the health status of heart failure patients receiving such an implant as part of their therapy.
A total of 720 patients with heart failure symptoms and a severely reduced pumping function receiving an ICD or a CRT-D device from up to 50 European clinical centers will be enrolled into the study. About 4 weeks after discharge from the implanting hospital, patients will be randomly assigned to prospective patient management by Home Monitoring or standard care groups. Patients in the Home Monitoring group will be monitored at least once per week, patients in the control group will not be monitored during the study, but their transmitted Home Monitoring data will be analyzed after their ending of participation in the study.
The health status of patients will be measured using the well established "Packer Score". This score is a combined measurement of death rates, hospital admission rates, heart failure symptom classification and quality of life. Patients will be classified at their end of study participation as worsened, unchanged, or improved based on these parameters. To this end, the health status of participating patients will be determined regularly during further outpatient follow ups. These will take place at regular intervals due to the standard care.
Additionally, some special parameters sent to the physician via Home Monitoring will be analyzed whether they could possibly predict an imminent worsening of a patient's health - leading to an unplanned hospital visit - so that it could perhaps be prevented in the future.
Patients remain within the study for 12 months after randomization or until their participation is ended prematurely, e.g. by withdrawal of their consent, a low data transmission rate, or death.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 720 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | IN-TIME: Influence of Home Monitoring on the Clinical Status of Heart Failure Patients |
| Study Start Date : | July 2007 |
| Actual Primary Completion Date : | March 2012 |
| Actual Study Completion Date : | August 2013 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Home Monitoring
ICD or CRT-D with Home Monitoring feature activated Home Monitoring data will be analyzed regularly and patients will be contacted and scheduled for additional follow-up after predefined events
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Device: ICD or CRT-D with Home Monitoring feature activated
Standard care + patient management by Home Monitoring
Other Names:
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Active Comparator: Control
ICD or CRT-D with Home Monitoring feature deactivated Patients will be treated as per standard of care in each participating clinic
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Device: ICD or CRT-D with Home Monitoring feature deactivated
Standard care |
- Composite Score of death, hospitalization for heart failure, NYHA class and global assessment (Packer Score) [ Time Frame: 12 months ]
- Rehospitalizations due to worsening heart failure; Correlation of Home Monitoring values with the clinical status; Incidence and reasons for Home Monitoring based interventions; Home Monitoring workflow analysis [ Time Frame: 12 months ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Indication for single chamber ICD, dual chamber ICD or CRT-D
- Chronic heart failure (≥ 3 months)
- NYHA Class II or III for 1 month prior to screening
- LVEF ≤ 35% within 3 months prior to screening
- Indication for therapy with diuretics
- Patient informed consent
Exclusion Criteria:
- Uncontrolled hypertension
- NYHA class I or IV
- Permanent atrial fibrillation
- Life expectancy < 1 year
- Restrictive, infiltrative or hypertrophic cardiomyopathy, constrictive pericarditis, acute myocarditis
- Severe mitral regurgitation
- Symptomatic aortic stenosis
- Tricuspid valve replacement
- Known drug or alcohol abuse
- Expected non-compliance
- Pregnancy
- Participation in another telemonitoring concept
- Participation in another 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): NCT00538356
Show 39 study locations
| Study Chair: | Gerhard Hindricks, Prof. Dr. | Herzzentrum Leipzig, Germany |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Biotronik SE & Co. KG |
| ClinicalTrials.gov Identifier: | NCT00538356 |
| Other Study ID Numbers: |
HS042 There is no secondary ID |
| First Posted: | October 2, 2007 Key Record Dates |
| Last Update Posted: | December 23, 2014 |
| Last Verified: | December 2014 |
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Heart failure Rehospitalization: Packer composite score |
Home Monitoring Cardiac resynchronization therapy Implantable cardioverter-defibrillator |
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Heart Failure Tachycardia Tachycardia, Ventricular Ventricular Fibrillation Heart Diseases |
Cardiovascular Diseases Arrhythmias, Cardiac Cardiac Conduction System Disease Pathologic Processes |