Combination therapy and balloon angioplasty for inoperable CTEPH
Effects of Combination Medical Therapy Followed by Balloon Pulmonary Angioplasty on Right Ventricular-PA Coupling and Hemodynamics in Chronic Thromboembolic Pulmonary Hypertension
This study is testing a new treatment that combines two medications with a procedure to see if it can help people with inoperable chronic thromboembolic pulmonary hypertension feel better and improve their heart function.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT05140525 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of a combination of medical therapies, specifically Riociguat and Macitentan, followed by balloon pulmonary angioplasty (BPA) on patients with inoperable or post-PTE residual chronic thromboembolic pulmonary hypertension (CTEPH). The researchers will assess hemodynamics and right ventricular function, including advanced measurements of right ventricular-pulmonary artery coupling, through invasive hemodynamic monitoring. The hypothesis is that this combined approach will lead to significant improvements in patient outcomes over time.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with CTEPH who are not suitable for pulmonary thromboendarterectomy (PTE) but are candidates for BPA.
Not a fit: Patients with moderate to severe heart disease, active cancer, or other serious comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance hemodynamic function and quality of life for patients with inoperable CTEPH.
How similar studies have performed: Previous studies have shown that BPA can provide significant hemodynamic benefits compared to medical therapy alone, indicating potential success for this combined approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial: 1. Age ≥ 18 years' old 2. Diagnosis of CTEPH 3. Not a candidate for PTE 4. Candidate for BPA based on suitable anatomy and disease burden 5. Treatment-naïve (no CTEPH or pulmonary arterial hypertension (PAH)-specific medical therapies) with plans for initiation of CTEPH/PAH-specific medical therapy and treatment with BPA. 6. Willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed). Exclusion Criteria: * Subjects presenting with any of the following will not be included in the trials: 1. Moderate to severe heart disease (LVEF \< 45% or severe LV Hypertrophy) 2. Sarcoidosis 3. Active cancer 4. Sickle cell anemia 5. Liver disease (Childs-Pugh class C) 6. Prisoners 7. Pregnant, planning pregnancy or lactating 8. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine) 9. Contraindication to riociguat or macitentan 10. Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements
Where this trial is running
Durham, North Carolina
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Sudarshan Rajagopal, MD, PhD — Duke Health System
- Study coordinator: Claudia Salazar
- Email: claudia.salazar@duke.edu
- Phone: +1 919 660 2026
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.