EXercise InTervention in Heart Failure (EXIT-HF)

Centro Hospitalar do Porto

Status: Completed

Conditions: Heart Failure

Treatments: Other: Exercise Training Program

Study type: Interventional

Funder types: Other

Identifiers

NCT04334603

2019.123

Details and patient eligibility

About

This is a pragmatic, non-inferiority clinical trial, enrolling heart failure patients who will be randomized to a 12-week exercise training program either centre-based or home-based with telemonitoring. The impact of this intervention will be assessed on established surrogate markers in HF such as maximal exercise capacity, plasma biomarkers and quality of life. The cost-effectiveness and overall satisfaction with the treatment will also be studied. In addition to measure the clinical and economic impact of this innovative way of delivering exercise, it is intended to unravel new molecular pathways and assess a pool of biomarkers that provide a wide mechanistic picture underlying the clinical effects of exercise.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of HFrEF and HFpEF according to criteria of the European Society of Cardiology (2016)
2. Clinical stability for ≥ 6 weeks
3. Optimal medical treatment for ≥ 6 weeks
4. Patients that are able to understand and follow the exercise prescription
5. Written informed consent

Exclusion criteria

1. Patients who have undertaken cardiac rehabilitation within the past 12 months
2. Patients who have received an intracardiac defibrillator (ICD), Cardiac 3. Resynchronisation therapy (CRT) or combined CRT/ICD device implanted in the last 6 weeks
3. Inability to exercise or conditions that may interfere with exercise intervention
4. Signs of ischemia during cardiopulmonary exercise test
5. Comorbidity that may influence one-year prognosis
6. Symptomatic and/or exercise induced cardiac arrhythmia or conduction disturbances
7. Currently pregnant or intend to become pregnant in the next year
8. Expectation of receiving a cardiac transplant in the next 6 months
9. Participation in another clinical trial
10. Patients who are unable to understand the study information or unable to complete the outcome questionnaires

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Home-based exercise training

Experimental group

Description:

The 12-week exercise-training program will include two sessions of combined exercise training per week, performed at home

Treatment:

Other: Exercise Training Program

Clinical-based exercise training

Active Comparator group

Description:

The 12-week exercise-training program will include two sessions of combined exercise training per week, performed at the hospital

Treatment:

Other: Exercise Training Program