Actively Recruiting
Effects of Combination Medical Therapy Followed by BPA on Right Ventricular-PA Coupling and Hemodynamics in CTEPH
Led by Dr Sudarshan Rajagopal · Updated on 2025-10-21
15
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
Sponsors
D
Dr Sudarshan Rajagopal
Lead Sponsor
J
Janssen Pharmaceutica N.V., Belgium
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of Combination Medical Therapy Followed by BPA on Right Ventricular-PA Coupling and Hemodynamics in CTEPH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH)
- Not a candidate for pulmonary thromboendarterectomy (PTE) surgery
- Suitable anatomy and disease burden for balloon pulmonary angioplasty (BPA)
- No prior CTEPH or pulmonary arterial hypertension (PAH)-specific medical treatments and plans to start these therapies along with BPA
- Willing and able to give informed consent and follow study procedures and visits
You will not qualify if you...
- Moderate to severe heart disease (left ventricular ejection fraction less than 45% or severe left ventricular hypertrophy)
- Sarcoidosis
- Active cancer
- Sickle cell anemia
- Liver disease classified as Childs-Pugh class C
- Prisoner status
- Pregnant, planning pregnancy, or breastfeeding
- Conditions that prevent MRI scanning (such as metal in eye, claustrophobia, or inability to lie down)
- Allergy or contraindication to riociguat or macitentan
- Medical or psychological conditions that increase risk or interfere with study compliance as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
C
Claudia Salazar
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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