Cardiovascular Effects of Preferred Home-based Exercise Training in Systolic Heart Failure (HOMEX-HF-P)

University Medicine Greifswald

Status and phase: Enrolling; Phase 3

Conditions: Chronic Heart Failure

Treatments: Behavioral: Adherence measures; Behavioral: exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT02051712

DZHK-HGW-001

Details and patient eligibility

About

The aim of the study is I. To assess whether an individualized exercise training program is superior as compared to usual care with respect to exercise tolerance, II. to assess whether intervention tools that aim to increase exercise adherence are superior to an individualized exercise training alone with respect to exercise tolerance and long-term effects, and III. to identify biomarkers that that may be implemented into novel intervention tools aiming to increase exercise adherence in patients with chronic heart failure.

Enrollment: 120 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women and men
• age 30-75 years
• chronic heart failure (NYHA II/III), left ventricular ejection fraction ≤40% be echo
• disease duration ≥ 6 month
• medical therapy accruing to guidelines (drug, devices, including CRT)
• written informed consent

Exclusion criteria

• acute myocarditis
• instable angina
• heart surgery (e.g. ICD implantation, bypass) with last 6 weeks; CRT implantation within the last 6 months before study start
• severe cardiovascular events (myocardial infarction, cardiac decompensation, ICD shock, PCI due to instable angina) < 6 weeks before study start
• preplanned hospital admission or intervention (e.g. planned revascularization, ICD implantation)
• uncorrected valve regurgitation or stenosis (> second degree)
• safety concerns regarding or other reasons against exercise training
• severe depression
• regular exercise training within the last 6 weeks
• life expectancy < 1 year

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Usual care

No Intervention group

Description:

Usual car accruing to guidelines

Individualized training

Experimental group

Description:

Individualized exercise training program in addition to usual care

Treatment:

Behavioral: exercise training

Individualized training plus adherence measures

Experimental group

Description:

Individualized exercise training plus measures to increase adherence

Treatment:

Behavioral: exercise training

Behavioral: Adherence measures