Training in HFpEF-PH

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHeidelberg University

About this trial

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.

Eligibility criteria

Qualifiers

Female and male patients ≥18 years

WHO/NYHA functional class II - IV

Preserved left ventricular ejection fraction ≥50%

Patients receiving optimized therapy including intensified treatment with diuretics and who have been stable for 1 month before entering the study.

Disqualifiers

Pre-capillary pulmonary hypertension (Group I; Group III; Group IV; Group V according to PH guidelines)

Congenital or acquired severe valvular diseases (severe aortic stenosis or insufficiency, severe mitral valve stenosis or insufficiency)

Pregnancy or lactation

Walking disability

Trial design

Treatments tested in this trial

  • Exercise rehabilitation
  • Standard treatment

Treatment groups

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators