Influence of Home Monitoring on the Clinical Status of Heart Failure Patients With an Impaired Left Ventricular Function

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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IN-TIME: Influence of Home Monitoring on the Clinical Status of Heart Failure Patients

Conditions
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Ventricular Fibrillation, Ventricular Tachycardia, Congestive Heart Failure

Intervention / Treatment
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* Device: ICD or CRT-D with Home Monitoring feature deactivated
* Device: ICD or CRT-D with Home Monitoring feature activated


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home Monitoring<br>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 | Device: ICD or CRT-D with Home Monitoring feature activated<br>* Standard care + patient management by Home Monitoring<br>* Other names: Home Monitoring Service Center;|
| Active Comparator: Control<br>ICD or CRT-D with Home Monitoring feature deactivated Patients will be treated as per standard of care in each participating clinic | Device: ICD or CRT-D with Home Monitoring feature deactivated<br>* Standard care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Score of death, hospitalization for heart failure, NYHA class and global assessment (Packer Score) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, Rehospitalization:, Packer composite score, Home Monitoring, Cardiac resynchronization therapy, Implantable cardioverter-defibrillator