NCT05464238Not yet recruiting
Training in HFpEF-PH
Implementation, Safety, Tolerability and Effect of Exercise and Respiratory Training on 6-minute Walking Distance in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (HFpEF): a Randomized Controlled Multicenter Trial in European Countries.
Source: ClinicalTrials.gov · Last updated 16 Sept 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 14 Jul 2022
- Start date
- 1 Feb 2023
- Primary completion date
- Dec 2025
- Lead sponsor
- Heidelberg University
- NCT number
- NCT05464238
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 1 Feb 2023 to the primary completion date, Dec 2025
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
- Severe lung disease: FEV1/FVC \<0.5 and total lung capacity \<60% of the normal value
Lab values
- 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
- Haemoglobin concentration less than 75% of the lower limit of normal
Other
- Pregnancy or lactation
- Walking disability
- Subject who participates in an interventional study during the course of this study
- Systolic blood pressure \<85 mmHg
- History or suspicion of inability to cooperate adequately.
Who the study is looking for
- Female and male patients ≥18 years
- WHO/NYHA functional class II - IV
- 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
- 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.
- Except for diuretics, medical treatment should not be changed during the study period.
- Able to understand and willing to sign the Informed Consent Form
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre for Pulmonary Hypertension at the Thoraxklinik Heidelberg, Heidelberg University Hospital Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania Coordinator of this site? Confirm its status | Vilnius | Lithuania | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.