Phase 4 Pulmonary Hypertension Trial, Recruiting NCT07356778 Sponsor: Kazuya Hosokawa Condition: Pulmonary Hypertension
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Phase 4 Pulmonary Hypertension Trial, Recruiting

NCT07356778
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 18 years of age or older
  • You have a heart condition involving an unrepaired hole or abnormal connection in the heart — specifically an ASD (a hole between the upper chambers), VSD (a hole between the lower chambers), or PDA (an abnormal blood vessel connection that didn't close after birth)
  • You have been on medication to treat high blood pressure in the lungs for at least 90 days, AND either your right heart pressure measurements from a recent procedure are above certain levels, OR an ultrasound of your heart shows specific abnormal readings along with a resting blood oxygen level at or below 92%
  • You are able to walk at least 100 metres (about 330 feet) during a standard 6-minute walking test
  • You are able to read and fill in questionnaires

Who may not be able to join:

  • Your heart condition is classified as the most severe functional level (WHO Class IV), or you have other unrepaired holes or abnormal connections in the heart beyond those listed above
  • You have severe kidney disease, severe liver disease, severe lung tissue disease, or your heart's main pumping chamber is working at less than 40% of normal capacity
  • You have previously been treated with a medication called sotatercept
  • You have a medical reason why you should not take sotatercept based on its official prescribing guidelines (confirm with trial site)
  • The trial doctor feels, for any other reason, that participation would not be appropriate for you (confirm with trial site)

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

Contact this trial

Phone: +81-92-642-5360

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
Kazuya Hosokawa
Registry
ClinicalTrials.gov
Start date
7 October 2025
Est. completion
31 August 2027

Where this trial is recruiting

🇯🇵 Japan

Primary endpoints

Change in 6-minute walk distance at 24 weeks from baseline

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