Telemedical Interventional Monitoring in Heart Failure (TIM-HF)

Charite University, Berlin, Germany2 sites in 1 country710 target enrollmentJanuary 2008

ConditionsChronic Heart Failure

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Chronic Heart Failure
Sponsor: Charite University, Berlin, Germany
Enrollment: 710
Locations: 2
Primary Endpoint: all cause mortality
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Superiority of additional Remote Patient Monitoring in patients with CHF In comparison to usual care in terms of:

reduction of mortality rate
reduction of hospitalizations
increasement of patients' quality of life

Detailed Description

The clinical trial assesses 710 patients over a period of at least 15 months each (2008 until 2010); all participants will continue to receive usual care from their GP. All patients will be examined at the beginning of the study and will undergo a check-up every 3 months. 355 of the patients will be randomly allocated to receive devices for Remote Patient Monitoring which will measure various parameters on a daily basis (e.g., weight, blood pressure, heart rate). The devices are mobile and can be used at home or elsewhere.

Registry

clinicaltrials.gov

Start Date

January 2008

End Date

October 2010

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Charite University, Berlin, Germany

Responsible Party

Principal Investigator

Friedrich Koehler

Senior Physician

Charite University, Berlin, Germany

Eligibility Criteria

Inclusion Criteria

•Ambulatory CHF NYHA II or III
•LVEF ≤ 35% and cardiac decompensation with hospitalization for heart failure or therapy with intravenous diuretics (.40 mg furosemide/day) within 24 months prior to enrolment or LVEF ≤ 25%, measured twice within past 6 months
•Optimal medical treatment for CHF (b-blocker, ACE-inhibitor/ ARB, diuretics) including ICD/CRT if indicated
•Age ≥ 18 years
•Informed consent

Exclusion Criteria

•Existence of any disease (HF excluded) reducing life expectancy to less than 1 year
•Insufficient compliance to telemonitoring or study visits
•Impairment to use the telemonitoring equipment or appear to study visits (e.g. dementia, impaired self-determination, lacking ability to communicate)
•Concurrent participation in other therapy trials
•Hospitalization for cardiac decompensation within 7 days before inclusion in trial
•Implanted cardiac assist system
•Unstable angina pectoris
•Congenital heart defect
•Primary heart valve disease
•Hypertrophic or restrictive cardiomyopathy

Outcomes

Primary Outcomes

all cause mortality

Secondary Outcomes

comp of the combined rate of cv death and hosp. for worsening HF;days lost due to cv death or HF hosp;cv mortality;Rate of cv hosp;Rate of hosp for HF;hosp for any reason;cv hosp;hosp for HF;duration of all hosp for HF;NYHA class; SF-36; PHQ-9 score