Training in HFpEF-PH

NCT05464238 · tracked via the Priya Life Science Germany tracker

Sponsor

Heidelberg University

Phase

Not applicable

Started

2023-02-01

Last updated

2022-09-16

Condition(s) studied

Pulmonary Hypertension Due to Left Heart DiseaseHeart Failure With Preserved Ejection Fraction

Investigational drug(s) / intervention(s)

Exercise rehabilitationStandard treatment

Exercise rehabilitation: The initial phase of exercise training will be closely monitored and will be based on a three-weeks in-hospital stay to adjust and teach the exercise training which will be continued at home for 12 more weeks. In-hospital stays will be arranged country specific and hospitalization time may range. The rehabilitation program comprises of interval ergometer training (20 minutes 5 days per week), dumbbell training (30 minutes 5 days per week), respiratory therapy (30 minutes 5 days per week), mental training and guided walks for 2-5 times/week.

Standard treatment: Standard treatment during study duration

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Female and male patients ≥18 years 2. WHO/NYHA functional class II - IV 3. PH with HFpEF diagnosed by right heart catheterisation showing: mean pulmonary arterial pressure (mPAP) ≥25mmHg at rest; pulmonary arterial wedge pressure (PAWP) ≥15mmHg at rest or LVEDP ≥16mmHg and/or PAWP≥25 mmHg during exercise, and 4. Preserved left ventricular ejection fraction ≥50% 5. Patients receiving optimized therapy including intensified treatment with diuretics and who have been stable for 1 month before entering the study. 6. Except for diuretics, medical treatment should not be changed during the study period. 7. Able to understand and willing to sign the Informed Consent Form Exclusion Criteria: 1. Pre-capillary pulmonary hypertension (Group I; Group III; Group IV; Group V according to PH guidelines) 2. Congenital or acquired severe valvular diseases (severe aortic stenosis or insufficiency, severe mitral valve stenosis or insufficiency) 3. Pregnancy or lactation 4. Walking disability 5. Subject who participates in an interventional study during the course of this study 6. Severe lung disease: FEV1/FVC \<0.5 and total lung capacity \<60% of the normal value 7. Active myocarditis, unstable angina pectoris, exercise induced ventricular arrhythmias, active liver disease, porphyria or elevations of serum transaminases \>3 x ULN (upper limit of normal) or bilirubin \>1.5 x ULN 8. Haemoglobin concentration less than 75% of the lower limit of normal 9. Systolic blood pressure \<85 mmHg 10. History or suspicion of inability to cooperate adequately.

Primary outcome measure(s)

6-minute walking distance — baseline to 15 weeks

Trial sites (2)

Facility	City	Region	Status
Centre for Pulmonary Hypertension at the Thoraxklinik Heidelberg, Heidelberg University Hospital	Heidelberg	Germany
Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania	Vilnius	Lithuania

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05464238 on ClinicalTrials.gov ↗ ← All trials in Germany