Effects of stopping riociguat on heart function in patients with CTEPH

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the impact of discontinuing riociguat on right heart function in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who have undergone balloon pulmonary angioplasty (BPA). The study aims to evaluate hemodynamic changes and right ventricular remodeling using advanced imaging techniques, including cardiac magnetic resonance and echocardiography. By assessing these effects, the trial seeks to clarify the optimal management strategy for patients who have achieved stability with BPA. Participants will undergo right heart catheterization to measure the hemodynamic impact of stopping riociguat after a stable treatment period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years old
* CTEPH was diagnosed and one of the following three factors was met: Pulmonary endarterectomy was technically impossible; Pulmonary endarterectomy is technically feasible, but the risk-benefit ratio is poor; Residual/recurrent pulmonary hypertension after pulmonary endarterectomy
* Subjects had been treated with BPA and had received a stable dose of riociguat for ≥12 weeks
* mPAP \< 30mmHg
* Male subjects and female subjects of reproductive age are required to use effective contraception for at least 28 days after signing the informed consent form. Male subjects are not allowed to donate sperm and female subjects are not allowed to breastfeed.
* Subjects voluntarily sign written informed consent

Exclusion Criteria:

* Severe hepatic and renal insufficiency (Child-Pugh Grade C/creatinine clearance \< 30ml/min·1.73m²)
* The presence of severe infectious disease or severe bleeding tendency
* Combined with pulmonary hypertension of other types than CTEPH
* Other pulmonary hypertension targeting drugs are being used
* The expected survival time with cancer or other diseases is less than 6 months
* Pregnancy, lactation
* Subjects are currently participating in an interventional clinical trial
* In the investigator's judgment, a subject's medical abnormality, physical condition, or medical history may affect his or her ability to participate in or complete the study

Where it's running

• Beijing Chao-Yang Hospital
  Beijing, China, China Recruiting
• China-Japan Friendship Hospital
  Beijing, China, China Recruiting
• Beijing Anzhen Hospital
  Beijing, China, China Recruiting

Study contacts

• Study coordinator: Suqiao Yang
• Email: yangsuqiao@126.com
• Phone: 010-85231217

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Registry of people with chronic thromboembolic pulmonary hypertension in Russia

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• Switching from Sildenafil to Riociguat for CTEPH Patients

  This study is testing if switching from sildenafil to riociguat can help people with Chronic Thromboembolic Pulmonary Hypertension feel better after they’ve already had balloon pulmonary angioplasty.

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• Using AI to improve imaging for pulmonary embolism diagnosis

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  Recruiting China-Japan Friendship Hospital · Beijing · NCT06526468

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.