Influence of Home Monitoring on the Clinical Status of Heart Failure Patients With an Impaired Left Ventricular Function (IN-TIME)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT00538356
First received: October 1, 2007
Last updated: December 5, 2013
Last verified: December 2013

October 1, 2007
December 5, 2013
July 2007
March 2012   (final data collection date for primary outcome measure)
Composite Score of death, hospitalization for heart failure, NYHA class and global assessment (Packer Score) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Composite Score of death, hospitalization for heart failure, NYHA class and global assessment (Packer Score) [ Time Frame: 12 months ]
Complete list of historical versions of study NCT00538356 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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 ]
Not Provided
Not Provided
 
Influence of Home Monitoring on the Clinical Status of Heart Failure Patients With an Impaired Left Ventricular Function
IN-TIME: Influence of Home Monitoring on the Clinical Status of Heart Failure Patients

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ventricular Fibrillation
  • Ventricular Tachycardia
  • Congestive Heart Failure
  • Device: ICD or CRT-D with Home Monitoring feature deactivated
    Standard care
  • Device: ICD or CRT-D with Home Monitoring feature activated
    Standard care + patient management by Home Monitoring
    Other Names:
    • Biotronik Home Monitoring
    • Home Monitoring Service Center
  • 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
    Intervention: Device: ICD or CRT-D with Home Monitoring feature activated
  • 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
    Intervention: Device: ICD or CRT-D with Home Monitoring feature deactivated

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
720
August 2013
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Germany,   Israel,   Czech Republic,   Latvia,   Australia,   Austria
 
NCT00538356
HS042, There is no secondary ID
No
Biotronik SE & Co. KG
Biotronik SE & Co. KG
Not Provided
Study Chair: Gerhard Hindricks, Prof. Dr. Herzzentrum Leipzig, Germany
Biotronik SE & Co. KG
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP