Combination Therapy and BPA for CTEPH
This study is looking at how a combination of two medications, Macitentan and Riociguat, followed by a procedure called balloon pulmonary angioplasty (BPA), affects people with chronic thromboembolic pulmonary hypertension (CTEPH). CTEPH is a type of high blood pressure in the lungs. Researchers want to see if this treatment improves how well your heart's right pumping chamber (right ventricle) works with your lung arteries. They will measure this at different times: before treatment, after medication, and after BPA. You might be able to join if you are at least 18 years old, have CTEPH that can't be treated with surgery, and haven't started CTEPH-specific medications yet. The study plans to enroll 15 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 15 participants.
- What's involved
- Participants will receive Macitentan and Riociguat medications, followed by balloon pulmonary angioplasty. Measurements will be taken at baseline, after medical therapy (up to 6 months), and after BPA (up to 12 months).
- Compensation
- Not stated in the trial record.
- Follow-up
- Measurements will be taken up to 12 months after starting treatment, specifically after balloon pulmonary angioplasty.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Effects of Combination Medical Therapy Followed by BPA on Right Ventricular-PA Coupling and Hemodynamics in CTEPH
At a glance
Conditions
NCT05140525
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Duke University Medical Center
Durham, North Carolinano site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Sudarshan Rajagopal, MD, PhD · PRINCIPAL_INVESTIGATOR · Duke Health System
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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Exclusion
What this trial measures
- Change in end-systolic elastance (Ees) divided by arterial elastance (Ea) (Ees/Ea) at three time points: Baseline, Timepoint 1 and Timepoint 2.Baseline (before starting all treatments); Timepoint 1 (after starting medical therapy; up to 6 months after baseline); Timepoint 2 (after balloon pulmonary angioplasty (BPA); up to 12 months after baseline)
Ees is a measure of right ventricular (RV) - pulmonary arterial (PA) coupling, with a normal value of Ees/Ea \> 0.8 (dimensionless - no units). For subjects with Ees/Ea \> 0.8 at the start of the study, we will evaluate the absolute change in Ees/Ea between timepoints. For those with an Ees/Ea \< 0.8, we will also determine whether participants have an improvement to \> 0.8.