EXercise InTervention in Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2022-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Home-based exercise training

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

Group Type EXPERIMENTAL

Exercise Training Program

Intervention Type OTHER

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

Clinical-based exercise training

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

Group Type ACTIVE_COMPARATOR

Exercise Training Program

Intervention Type OTHER

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

Interventions

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Exercise Training Program

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No