Table 1 The World Health Organization trial registration data set: structured summary
Data category | Information |
|---|---|
Primary registry and trial identifying number | ClinicalTrials.gov Identifier: NCT05464238 |
Date of registration in primary registry | July 19, 2022 |
Secondary identifying numbers | 2019-04ET |
Source(s) of monetary or material support | Heidelberg University |
Primary sponsor | Heidelberg University |
Secondary sponsor(s) | N/ A |
Contact for public and scientific queries | Ekkehard Grünig, MD ekkehard.gruenig@med.uni-heidelberg.de Nicola Benjamin, MSc nicola.benjamin@med.uni-heidelberg.de |
Public title | Safety and effectiveness of standardized exercise training in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction |
Scientific title | Implementation, safety, tolerability, and effect of exercise and respiratory training on 6-min walking distance in patients with pulmonary hypertension and heart failure with preserved ejection fraction (HFpEF): a randomized controlled multicenter trial in European countries |
Countries of recruitment | Germany, Lithuania |
Health condition(s) or problem(s) studied | Efficacy and safety of exercise and respiratory training for patients diagnosed with pulmonary hypertension associated with heart failure with preserved ejection fraction (HFpEF) |
Intervention(s) | Active Comparator: Exercise rehabilitation Placebo Comparator: Standard treatment (waiting group) |
Key inclusion and exclusion criteria | Inclusion criteria: |
- Female and male patients ≥ 18 years | |
- WHO/NYHA functional classes II–IV | |
- PH with HFpEF diagnosed by right heart catheterization | |
- 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 criteria: | |
- Pre-capillary pulmonary hypertension | |
- Congenital or acquired severe valvular diseases | |
- Walking disability | |
- Subject who participates in an interventional study during the course of this study | |
- Severe lung disease | |
- Active myocarditis, unstable angina pectoris, exercise-induced ventricular arrhythmias | |
- Hemoglobin concentration less than 75% of the lower limit of normal | |
- Systolic blood pressure < 85 mmHg | |
- Pregnancy or lactation | |
- History or suspicion of inability to cooperate adequately | |
Study type | Interventional, multicenter trial; intervention model description: randomized, controlled, parallel-group with crossover of the control group; masking: single (outcomes assessor); primary purpose: treatment |
Date of first enrolment (estimated) | February 1, 2023 |
Target sample size | 90 |
Recruitment status | Not yet recruiting |
Primary outcome(s) | Changes in 6-min walking distance (time frame: baseline to 15 weeks) |
Key secondary outcomes | Changes in peak exercise oxygen uptake, quality of life, echocardiographic parameters, natriuretic peptides (time frame: baseline to 15 weeks) |