Physical training for patients with pulmonary arterial hypertension and congenital heart defects
Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life in Patients With Severe Associated Pulmonary Arterial Hypertension (APAH) as Part of a Congenital Heart Defect With / Without Eisenmenger's Syndrome
This study tests whether a special exercise program can help people with pulmonary arterial hypertension caused by congenital heart defects feel better and improve their ability to be active.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Heidelberg University Academic / other |
| Locations | 1 site (Heidelberg) |
| Trial ID | NCT01397110 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of respiratory and exercise therapy on patients suffering from associated pulmonary arterial hypertension (APAH) due to congenital heart defects, including those with Eisenmenger syndrome. It aims to assess improvements in exercise capacity, quality of life, functional class, oxygen consumption, and right ventricular function. Participants will undergo a structured physical training program while being monitored for their health outcomes. The study focuses on individuals diagnosed with severe APAH, ensuring they have been stable on targeted medication for a minimum of two months prior to enrollment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with APAH related to congenital heart defects, classified as WHO functional class II-IV.
Not a fit: Patients with severe walking disturbances or those with acute diseases or serious lung conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life and physical capabilities of patients with severe pulmonary arterial hypertension.
How similar studies have performed: Previous studies have shown promising results with similar therapeutic approaches in improving outcomes for patients with pulmonary arterial hypertension.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * signed consent form * men and women\> 18 years \<80 years * APAH with congenital heart defects with / without Eisenmenger syndrome (WHO functional class II-IV), invasively diagnosed by right heart and left heart catheterization: mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg, with targeted PAH medication for at least two months stable before study inclusion (exception: compensated WHO class II without vasodilating drug therapy) Exclusion Criteria: * Pregnancy or lactation * Change in medication during the last 2 months * severe walking disturbance * uncertain diagnoses * No previous invasively confirmation of PH * acute diseases, infections, fever * Serious lung disease with FEV1 \<50% or TLC \<70% of target * Further exclusion criteria are the following diseases: active myocarditis, unstable angina pectoris, exercise-induced ventricular arrhythmias, recurrent syncope within 4 weeks before study entry
Where this trial is running
Heidelberg
- : Center for pulmonary Hypertension, Thoraxclinic Heidelberg — Heidelberg, Germany (Recruiting)
Study contacts
- Study coordinator: Ekkehard Gruenig, MD
- Email: ekkehard.gruenig@med.uni-heidelberg.de
- Phone: +49 6221 396 8053
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.