Clinical trial NCT04334603: EXercise InTervention in Heart Failure
Official title: EXercise InTervention in Heart Failure (EXIT-HF): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
Home-based exercise
Maximal oxygen consumption
Cost-effectiveness
Lead sponsor: Centro Hospitalar do Porto
Sponsor class: OTHER
Collaborators: name: Universidade do Porto
name: Aveiro University
First posted: 2020-04-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Peak oxygen uptake (ml/kg/min)
timeFrame: Change from baseline in peak oxygen uptake (ml/kg/min) at 3 months
Secondary outcomes:
measure: 6-min walk test (6MWT) distance
timeFrame: Change from baseline to 3 months, and to 12 months.
measure: Health status (EQ-5D-5L)
timeFrame: Change from baseline to 3 months, and to 12 months.
measure: Health-related quality of life (MLHFQ)
timeFrame: Change from baseline to 3 months, and to 12 months.
measure: Anxiety and Depression (HADS)
timeFrame: Change from baseline to 3 months, and to 12 months.
measure: Disutility
timeFrame: Evaluate at 3th month
measure: Physical activity (steps/day)
timeFrame: Change from baseline to 3 months, and to 12 months.
measure: Daily physical activity levels (min/day)
timeFrame: Change from baseline to 3 months, and to 12 months.
measure: Dyspnea
timeFrame: Change from baseline to 3 months, and to 12 months.
measure: Mediterranean diet
timeFrame: Change from baseline to 3 months, and to 12 months.
measure: Hand grip strength
timeFrame: Change from baseline to to 3 and to 12 months.
measure: Circulating number of endothelial progenitor cells, circulating endothelial cells, nitric oxide and endothelial Nitric Oxide Synthase
timeFrame: Change from baseline to 3 months
measure: Biomarkers (pg/ml)
timeFrame: Change from baseline to 3 months
measure: Biomarkers (mg/L)
timeFrame: Change from baseline to 3 months
measure: Concentration of plasma exosomes
timeFrame: Change from baseline to 3 months
measure: Percentage of protein aggregates
timeFrame: Change from baseline to 3 months
measure: Cost-effectiveness of home-based exercise Vs. clinical-base exercise
timeFrame: At 12th month
measure: Physical fitness levels evaluation
timeFrame: Change from baseline to 3 and to 12 months.
Other outcomes:
measure: Exploratory analyses of urine proteome
timeFrame: Change from baseline to 3 months
Locations:
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto
Study officials:
affiliation: Cardiology Service of Centro Hospitalar do Porto
name: Mário Santos, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: