Phase 4 Pulmonary Hypertension Trial, Recruiting NCT05825417 Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust Condition: Pulmonary Hypertension
Back to Pulmonary Hypertension

Phase 4 Pulmonary Hypertension Trial, Recruiting

NCT05825417
Recruiting Phase 4

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:

  • You are between 18 and 80 years old
  • You are able to understand and sign a consent form agreeing to take part
  • You have been diagnosed with pulmonary arterial hypertension (high blood pressure in the lungs) that is either inherited, has no known cause, or was caused by certain drugs, toxins, or a connective tissue disease (such as lupus or scleroderma)
  • You have been on a stable combination of approved lung blood pressure medications (called ERAs and PDE5 inhibitors) for at least 1 month before the study screening (unless you were unable to tolerate these medications)
  • Your condition is classified as WHO functional class III, meaning symptoms significantly limit your physical activity
  • Your right heart catheterisation (a test measuring pressures in the heart and lungs) showed specific pressure and resistance readings at the time of your diagnosis (confirm with trial site)
  • You are able to walk more than 50 metres in a 6-minute walking test
  • Your kidneys are working at an adequate level, based on a blood test result (confirm with trial site)
  • Your doctor has determined that your current treatment is not working well enough

Who may not be able to join:

  • You are unable to understand or sign a consent form
  • You are currently pregnant
  • You have ever had a blood clot in the lungs that happened without a clear cause
  • You have an active infection at the time of screening (though you may be able to rescreen once the infection has cleared)
  • Your pulmonary arterial hypertension is related to HIV, liver disease, a parasitic infection called schistosomiasis, or a heart defect you were born with
  • Your high lung blood pressure is caused by left-sided heart problems, lung disease, blood clots, or other mixed causes
  • You are unable to tolerate aspirin or a type of blood-thinning medication called a P2Y12 inhibitor (such as clopidogrel)
  • You have a known allergy or serious reaction to the study drugs selexipag or riociguat
  • Your kidneys are not functioning well enough, based on a blood test result (confirm with trial site)
  • You have anaemia, meaning your blood count (haemoglobin) is below a certain level
  • You have significant heart valve problems or other serious heart conditions affecting the left side of your heart (confirm with trial site for specific details)

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 27 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Alexander Rothman, MD / PhD, University of Sheffield

Phone: +44 (0) 114 2159550

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 4
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Registry
ClinicalTrials.gov
Start date
14 June 2023
Est. completion
1 January 2027

Where this trial is recruiting

🇬🇧 United Kingdom

Primary endpoints

Right Ventricular Stroke Volume (RVSV) flow on each therapy measured by MRI RSVS (flow) on each therapy measured by MRI

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: 27 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