Telemedical Interventional Monitoring in Heart Failure

Phase 3

Completed

• Conditions: Chronic Heart Failure
• Interventions: Device: Remote patient monitoring (Partnership for the Heart); Device: Usual care group

• Registration Number: NCT00543881
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study First Submitted: 2007-10-11
• Study First Submitted QC: 2007-10-12
• Study First Posted: 2007-10-15
• Study Start: 2008-01
• Primary Completion: 2010-07
• Study Completion: 2010-10
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-20
• Last Update Posted: 2016-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 710

Inclusion Criteria

1. Ambulatory CHF NYHA II or III
2. 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
3. Optimal medical treatment for CHF (b-blocker, ACE-inhibitor/ ARB, diuretics) including ICD/CRT if indicated
4. Age ≥ 18 years
5. Informed consent

Exclusion Criteria

1. Existence of any disease (HF excluded) reducing life expectancy to less than 1 year
2. Insufficient compliance to telemonitoring or study visits
3. Impairment to use the telemonitoring equipment or appear to study visits (e.g. dementia, impaired self-determination, lacking ability to communicate)
4. Pregnancy
5. Concurrent participation in other therapy trials
6. Hospitalization for cardiac decompensation within 7 days before inclusion in trial
7. Implanted cardiac assist system
8. Unstable angina pectoris
9. Congenital heart defect
10. Primary heart valve disease
11. Hypertrophic or restrictive cardiomyopathy
12. Arrhythmogenic right ventricular cardiomyopathy
13. Acute myocarditis diagnosis ,1 year
14. Actively listed for heart transplantation
15. Planned revascularization or CRT implantation
16. Chronic renal insufficiency with creatinine .2.5 mg/dl
17. Liver cirrhosis
18. Known alcohol or drug abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Remote patient monitoring (Partnership for the Heart)	Interventional group
2	Usual care group	Usual care group

Primary Outcome Measures

Name	Time	Method
all cause mortality

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Robert-Bosch-Krankenhaus; 🇩🇪 Stuttgart, Germany

Charité - Universitaetsmedizin Berlin; 🇩🇪 Berlin, Germany