Telemedical Interventional Monitoring in Heart Failure (TIM-HF)

Charité University Medicine Berlin

Status and phase: Completed; Phase 3

Conditions: Chronic Heart Failure

Treatments: Device: Remote patient monitoring (Partnership for the Heart); Device: Usual care group

Study type: Interventional

Funder types: Other

Identifiers

NCT00543881

01MG531

Details and patient eligibility

About

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

Full 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.

Enrollment: 710 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

710 participants in 2 patient groups

1

Experimental group

Description:

Interventional group

Treatment:

Device: Remote patient monitoring (Partnership for the Heart)

2

Active Comparator group

Description:

Usual care group

Treatment:

Device: Usual care group