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NCT05140525 · ClinicalTrials.gov registry record · Phase 3
Effects of Combination Medical Therapy Followed by BPA on Right Ventricular-PA Coupling and Hemodynamics in CTEPH
A Phase 3 study of CTEPH, sponsored by Dr Sudarshan Rajagopal.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT05140525: Recruiting Phase 3 study of CTEPH, sponsored by Dr Sudarshan Rajagopal.
NCT05140525 is a Phase 3 study of CTEPH that is actively recruiting participants, run by Dr Sudarshan Rajagopal. The registered enrollment target is 15 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05140525, a Phase 3 study of CTEPH, is actively recruiting participants, sponsored by Dr Sudarshan Rajagopal.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Macitentan Tablets
- DRUG Riociguat
- DEVICE balloon pulmonary angioplasty
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2025-01-27 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 3 |
What NCT05140525 shows while recruiting
NCT05140525 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 1 condition, with CTEPH appearing as the primary indexed condition, and to 3 interventions - of which Macitentan Tablets is the first listed.
NCT05140525 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05140525 about?
NCT05140525 is a clinical study titled "Effects of Combination Medical Therapy Followed by BPA on Right Ventricular-PA Coupling and Hemodynamics in CTEPH". 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 hemodynamic...
What is the current status of trial NCT05140525?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 15 participants. The study started on 2025-01-27. Estimated completion is 2026-12-31.
What conditions does trial NCT05140525 study?
This clinical trial studies the following conditions: CTEPH.
What interventions are being tested in trial NCT05140525?
The interventions under investigation include: Macitentan Tablets (DRUG), Riociguat (DRUG), balloon pulmonary angioplasty (DEVICE).
Who is sponsoring clinical trial NCT05140525?
This trial is sponsored by Dr Sudarshan Rajagopal, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05140525 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for CTEPH
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05140525's enrollment target sits among peer trials
15 1978th of 2000 higher than 18 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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