Telemedical Interventional Management in Heart Failure II (TIM-HF2)

Charité University Medicine Berlin

Status and phase: Completed; Phase 3

Conditions: Chronic Heart Failure

Treatments: Other: Usual Care; Device: Remote Patient Management

Study type: Interventional

Funder types: Other

Identifiers

NCT01878630

13KQ0904B

Details and patient eligibility

About

Superiority of additional Remote Patient Management (RPM) in patients with chronic heart failure (CHF) in comparison to usual care in terms of, e.g.:

• days lost due to unplanned cardiovascular hospitalization or death
• all-cause mortality
• cardiovascular mortality
• quality of life

Full description

The clinical trial assesses 1,500 patients over a period of 12 months each (2013 until 2015). All participants will continue to receive usual care from their general practitioner and specialist. All patients will be examined at the beginning of the study and will undergo a check-up every 3 months. 750 of the patients will be randomly allocated to receive devices for Remote Patient Management (RPM) 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: 1,571 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• chronic heart failure New York Heart Association (NYHA) class II or III
• echocardiographically determined left ventricular ejection fraction (LVEF) ≤45% or >45% + minimum 1 diuretic in permanent medicinal therapy
• hospitalization due to decompensated HF within the last 12months before randomization
• informed consent
• Depression score PHQ-9: <10

Exclusion criteria

• hospitalization within the last 7 days before randomization
• implanted cardiac assist system
• acute coronary syndrome within the last 7 days before randomization
• high urgent listed for heart transplantation (HTx)
• planned revascularization, Transcatheter Aortic Valve Implantation (TAVI), MitraClip and/or Cardiac Resynchronization Therapy (CRT)-implantation within the last 3 months before randomization
• revascularization and/or CRT-implantation within 28 days before randomization
• known alcohol or drug abuse
• terminal renal insufficiency with hemodialysis
• impairment or unwillingness to use the telemonitoring equipment (e.g. dementia, impaired self-determination, lacking ability to communicate)
• existence of any disease reducing life expectancy to less than 1 year
• age <18 years
• pregnancy
• participation in other treatment studies or remote patient management programmes (register studies possible)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,571 participants in 2 patient groups

Remote Patient Management

Experimental group

Description:

intervention group

Treatment:

Device: Remote Patient Management

Usual Care

Active Comparator group

Description:

control group

Treatment:

Other: Usual Care