Clinical Trial

Training in HFpEF-PH

Study acronym: TRAIN HFpEF
Not Yet Recruiting
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Record status
This record was last updated September 16, 2022 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
Exercise interventions alone or as a component of a comprehensive cardiac rehabilitation program for patients with heart failure (HFrEF and HFpEF) have already shown to reduce the risk of hospitalisations due to HF and improved exercise capacity and health-related quality of life. Two meta-analyses have confirmed the beneficial effects in cardiorespiratory fitness and quality of life. The effects of exercise training on systolic and diastolic function remain inconclusive. Due to the positive results of exercise training in HFpEF, cardiac rehabilitation is recommended (Class I, level A) to be integrated into the overall provision of HF care. However, none of these studies focused on concomitant PH in HFpEF. Exercise training in patients with pulmonary hypertension has already shown to improve exercise capacity, quality of life and peak oxygen consumption, which was confirmed by three meta-analyses and a Cochrane review. Though different diagnostic subgroups have already been enrolled in PH exercise training studies, they mainly included pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. Data on combined PH and HFpEF is still lacking. As recently pointed out by Arena et al. there may thus be an exercise training volume/intensity which may be detrimental to the RV in patients with HF and concomitant PH. This study is sought to investigate whether a specialized training program is safe and tolerable and may improve exercise capacity, quality of life, hemodynamics, diastolic dysfunction and biomarkers in patients with PH and HFpEF.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2022-07-14; most recent amendment 2022-09-14.
Status change: Recruiting → Not Yet Recruiting 2022-09-14
Trial Details
NCT Number NCT05464238
Lead Sponsor Heidelberg University
Conditions Pulmonary Hypertension Due to Left Heart Disease, Heart Failure With Preserved Ejection Fraction
Enrollment 90 participants
Start Date 2023-02-01
Primary Completion 2025-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2022-09-16