NCT05140525TerminatedPhase 3
Effects of Combination Medical Therapy Followed by BPA on Right Ventricular-PA Coupling and Hemodynamics in CTEPH
Effects of Combination Medical Therapy Followed by Balloon Pulmonary Angioplasty on Right Ventricular-PA Coupling and Hemodynamics in Chronic Thromboembolic Pulmonary Hypertension
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Reason given: Sponsor Requested
Brief summary (registry, in English)
The main goal of this study is to determine the effects of combination medical therapy (Riociguat and Macitentan) and balloon pulmonary angioplasty (BPA) on hemodynamics and right ventricular (RV) function (including advanced assessments of RV-pulmonary artery (PA) coupling from invasive hemodynamics) in participants with inoperable or post-PTE residual CTEPH.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 7 (actual)
- First submitted
- 28 Oct 2021
- Start date
- 27 Jan 2025
- Primary completion date
- 26 Mar 2026
- Lead sponsor
- Dr Sudarshan Rajagopal
- Diseases
- Pulmonary arterial hypertension
- NCT number
- NCT05140525
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Subjects presenting with any of the following will not be included in the trials:
- Moderate to severe heart disease (LVEF < 45% or severe LV Hypertrophy)
- Sarcoidosis
- Active cancer
- Sickle cell anemia
- Liver disease (Childs-Pugh class C)
- Prisoners
- Pregnant, planning pregnancy or lactating
- Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)
- Contraindication to riociguat or macitentan
- 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
Who the study is looking for
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
- Age ≥ 18 years' old
- Diagnosis of CTEPH
- Not a candidate for PTE
- Candidate for BPA based on suitable anatomy and disease burden
- 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.
- Willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Medical Center | Durham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.