Phase 3 Pulmonary Hypertension Trial, Recruiting NCT05140525 Sponsor: Dr Sudarshan Rajagopal Condition: Pulmonary Hypertension
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Phase 3 Pulmonary Hypertension Trial, Recruiting

NCT05140525
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are 18 years of age or older
  • People who have been diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH), a condition where blood clots cause high blood pressure in the lungs
  • People who are not suitable for surgery to remove the blood clots (called pulmonary thromboendarterectomy or PTE)
  • People whose blood vessel anatomy and disease are suitable for a non-surgical procedure called balloon pulmonary angioplasty (BPA), which opens up blocked blood vessels in the lungs
  • People who have not yet started any specific medical treatment for CTEPH or related pulmonary hypertension, but who are planning to begin both medication and BPA treatment
  • People who are willing and able to give their agreement to participate and to attend scheduled visits and follow study requirements

Who may not be able to join:

  • People with moderate to severe heart problems, specifically a weakened heart pump or significantly enlarged heart muscle
  • People who have sarcoidosis (an inflammatory condition affecting multiple organs)
  • People with active cancer
  • People who have sickle cell anaemia
  • People with severe liver disease
  • People who are currently imprisoned
  • People who are pregnant, planning to become pregnant, or currently breastfeeding
  • People who are unable to have an MRI scan, for example due to metal fragments in the eye, severe claustrophobia, or inability to lie flat
  • People for whom the medications riociguat or macitentan are not medically appropriate
  • People whose physical or mental health conditions, in the treating doctor's judgement, could put them at unnecessary risk or make it difficult to follow the study requirements

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Sudarshan Rajagopal, MD, PhD, Duke Health System

Phone: +1 919 660 2026

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Dr Sudarshan Rajagopal
Registry
ClinicalTrials.gov
Start date
27 January 2025
Est. completion
31 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in end-systolic elastance (Ees) divided by arterial elastance (Ea) (Ees/Ea) at three time points: Baseline, Timepoint 1 and Timepoint 2.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov