Treatment for exercise-related lung issues after surgery for blood clots in the lungs
Treatment of Exercise-Induced Pulmonary Vascular Dysfunction in Symptomatic Patients After Pulmonary Thromboendarterectomy
This study is testing if a medication called Riociguat can help people who have trouble exercising after surgery for blood clots in their lungs feel better and improve their quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT03409588 on ClinicalTrials.gov |
What this trial studies
This open-label study evaluates the effectiveness of Riociguat in patients who experience ongoing exercise intolerance at least six months after undergoing pulmonary endarterectomy (PEA) or balloon pulmonary angioplasty (BPA) for chronic thromboembolic pulmonary hypertension (CTEPH). The study aims to determine if this medication can improve exercise capacity and overall quality of life in affected individuals. Participants will be monitored for their ability to perform an exercise protocol as part of the assessment.
Who should consider this trial
Good fit: Ideal candidates are adults who have undergone PEA or BPA for CTEPH at least six months prior and report ongoing exercise limitations.
Not a fit: Patients with residual pulmonary hypertension or those currently on PAH-specific vasodilator therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve exercise capacity and quality of life for patients suffering from exercise intolerance after pulmonary surgery.
How similar studies have performed: While this approach is focused on a specific patient population, similar studies using Riociguat have shown promise in treating pulmonary hypertension, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients who underwent PTE or BPA for Chronic thromboembolic pulmonary hypertension (CTEPH) at least six months prior to screening and report ongoing subjective exercise limitation, * able to give consent * able to perform a exercise protocol Exclusion Criteria: * Patients with known Residual Pulmonary Hypertension (RPH) by RHC following PTE for CTEPH * ongoing PAH-specific vasodilator therapy * known contraindication to riociguat * a physical limitation to completing an exercise protocol
Where this trial is running
Aurora, Colorado
- University of Colorado, Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Todd Bull, MD — University of Colorado, Denver
- Study coordinator: Cheri Abbott, RN
- Email: Cheryl.Abbott@ucdenver.edu
- Phone: 303-724-7466
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.