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Clinical Trials/NCT04334603
NCT04334603CompletedNot Applicable

EXercise InTervention in Heart Failure (EXIT-HF): a Randomized Controlled Trial

Centro Hospitalar do Porto2 sites in 1 country120 target enrollmentStarted: November 1, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
120
Locations
2
Primary Endpoint
Peak oxygen uptake (ml/kg/min)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Peak oxygen uptake (ml/kg/min)

Time Frame: Change from baseline in peak oxygen uptake (ml/kg/min) at 3 months

Patients will be submitted to cardiopulmonary treadmill exercise tests at baseline and after 3 moths

Secondary Outcomes

  • Disutility(Evaluate at 3th month)
  • 6-min walk test (6MWT) distance(Change from baseline to 3 months, and to 12 months.)
  • Health status (EQ-5D-5L)(Change from baseline to 3 months, and to 12 months.)
  • Hand grip strength(Change from baseline to to 3 and to 12 months.)
  • Health-related quality of life (MLHFQ)(Change from baseline to 3 months, and to 12 months.)
  • Anxiety and Depression (HADS)(Change from baseline to 3 months, and to 12 months.)
  • Physical activity (steps/day)(Change from baseline to 3 months, and to 12 months.)
  • Daily physical activity levels (min/day)(Change from baseline to 3 months, and to 12 months.)
  • Dyspnea(Change from baseline to 3 months, and to 12 months.)
  • Percentage of protein aggregates(Change from baseline to 3 months)
  • Physical fitness levels evaluation(Change from baseline to 3 and to 12 months.)
  • Mediterranean diet(Change from baseline to 3 months, and to 12 months.)
  • Concentration of plasma exosomes(Change from baseline to 3 months)
  • Circulating number of endothelial progenitor cells, circulating endothelial cells, nitric oxide and endothelial Nitric Oxide Synthase(Change from baseline to 3 months)
  • Biomarkers (mg/L)(Change from baseline to 3 months)
  • Biomarkers (pg/ml)(Change from baseline to 3 months)
  • Cost-effectiveness of home-based exercise Vs. clinical-base exercise(At 12th month)

Investigators

Sponsor
Centro Hospitalar do Porto
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mário André Silva Santos

Cardiologist, MD, PhD

Centro Hospitalar do Porto

Study Sites (2)

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