Exercise and breathing training for pulmonary hypertension with heart failure
Tests an exercise program in adults with pulmonary hypertension and HFpEF.
Plain-language title generated from the registry record
Registry title: Training in HFpEF-PH
Key facts
- Where
- Heidelberg, GermanySee the site
Where in Germany
- Centre for Pulmonary Hypertension at the Thoraxklinik Heidelberg, Heidelberg University HospitalHeidelberg, GermanyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Heidelberg University
- Trial code
- NCT05464238
- Record updated
- 16 September 2022
- Original description
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.Read full original descriptionShow less
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.
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.
Inclusion: 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.
Exclusion: 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; 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; 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.