Status:
COMPLETED
EXercise InTervention in Heart Failure
Lead Sponsor:
Centro Hospitalar do Porto
Collaborating Sponsors:
Universidade do Porto
Aveiro University
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 telemonitorin...
Eligibility Criteria
Inclusion
- 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
- Patients who have undertaken cardiac rehabilitation within the past 12 months
- Patients who have received an intracardiac defibrillator (ICD), Cardiac 3. 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
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04334603
Start Date
November 1 2019
End Date
December 30 2022
Last Update
February 23 2023
Active Locations (1)
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1
Centro Hospitalar do Porto
Porto, Portugal, 4099-001