RecruitingRare disease

Testing the safety of stopping riociguat in patients with chronic thromboembolic pulmonary hypertension after successful balloon pulmonary angioplasty treatment

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH), a condition where blood clots cause high blood pressure in the lungs' arteries. The study examines the effects of stopping treatment with riociguat, a medication that helps widen blood vessels in the lungs, after patients have undergone a procedure called balloon pulmonary angioplasty that opens up narrowed blood vessels.

The purpose of this research is to determine if it is safe to stop taking riociguat in patients whose blood pressure in the lungs has improved after the balloon procedure. The medication is given as film-coated tablets, with patients taking up to 7.5 milligrams per day. Some patients will continue taking riociguat, while others will stop the medication.

The study will last 16 weeks, during which doctors will monitor the blood pressure in patients' lungs and other health measures. Throughout the study, various tests will be performed to check how well the heart and lungs are working, including measurements of exercise capacity and quality of life. This will help determine if stopping the medication is a safe option for patients who have shown improvement after their procedure.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial qualification
You will be evaluated for participation if you have chronic thromboembolic pulmonary hypertension (CTEPH) and have completed balloon pulmonary angioplasty treatment
Your pulmonary artery pressure must be below 30 mmHg, as measured within the last 3 months
You must be currently taking riociguat (Adempas) as your only treatment, which was started before or within 2 weeks after your first balloon pulmonary angioplasty
Step 2
Treatment groups
You will be randomly assigned to one of two groups:
Group 1: Continue taking riociguat tablets (2.5 mg) as usual
Group 2: Gradually stop taking riociguat tablets
Step 3
Study duration
The study will last for 16 weeks
During this time, your health will be monitored through various tests and examinations
Step 4
Monitoring and tests
Your heart and lung function will be checked regularly
Tests will include:
- Blood tests
- Walking tests to measure exercise capacity
- Heart ultrasound
- Quality of life questionnaires
- Heart catheterization at the end of the study
Step 5
Safety monitoring
Your blood pressure and other vital signs will be regularly monitored
Any side effects or health changes will be documented
If your condition worsens, appropriate medical care will be provided

Who can join the trial?

6 criteria

Must be 18 years of age or older
Must have been diagnosed with Chronic thromboembolic pulmonary hypertension (CTEPH) according to European guidelines
Must have had a right heart catheterization (RHC) follow-up test within the last 3 months after balloon pulmonary angioplasty (BPA), or be scheduled for one. The test should show mean pulmonary artery pressure less than 30 mmHg
Must be taking riociguat as the only treatment, which was started either before or within 2 weeks after the first balloon pulmonary angioplasty procedure
Must be able to attend all scheduled study visits and follow all study requirements
Must be able to understand and sign an informed consent form in Dutch

Who cannot join the trial?

11 criteria

Patients with mean pulmonary artery pressure (mPAP) equal to or higher than 30 mmHg (a measure of blood pressure in the lungs)
Patients who have not completed at least 6 months after their last balloon pulmonary angioplasty (BPA) procedure (a treatment to open blocked blood vessels in the lungs)
Patients who are not currently taking riociguat (a medication used to treat pulmonary hypertension)
Patients under 18 years of age
Patients who are unable to provide informed consent
Patients who have had major surgery within the last 3 months
Pregnant or breastfeeding women
Patients with severe kidney or liver problems
Patients with uncontrolled high blood pressure
Patients with active bleeding or at high risk of bleeding
Patients participating in other clinical trials

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Verified sites

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Amsterdam UMC
Responsive
Amsterdam, The Netherlands
St. Antonius Ziekenhuis
Verified
Nieuwegein, The Netherlands

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Investigated drugs

Riociguat is a medication used to treat chronic thromboembolic pulmonary hypertension (CTEPH), a condition where blood pressure in the lungs is high due to blood clots. The medication works by relaxing and widening blood vessels in the lungs, which helps to reduce blood pressure and make breathing easier for patients. It is taken orally and helps improve the ability to exercise and perform daily activities. Balloon Pulmonary Angioplasty (BPA) is a medical procedure, not a medication, where a tiny balloon is inserted into narrowed blood vessels in the lungs. The balloon is inflated to widen these vessels, improving blood flow and reducing pressure in the lungs. This procedure is performed by specialists in a hospital setting and may require multiple sessions to treat all affected vessels.

Riociguat

What is already known about the treatment

Riociguat – An oral medication administered in tablet form that is approved for treating Chronic Thromboembolic Pulmonary Hypertension (CTEPH). This drug works by stimulating soluble guanylate cyclase (sGC), which helps blood vessels relax and widen, leading to improved blood flow in the lungs and reduced blood pressure in the pulmonary arteries. As a member of the soluble guanylate cyclase stimulator class of medications, Riociguat represents a significant advancement in CTEPH treatment, particularly for patients who cannot undergo surgery or have persistent symptoms after surgical intervention. The medication has demonstrated effectiveness in improving exercise capacity and reducing symptoms in clinical trials, making it an important therapeutic option for managing pulmonary hypertension.

Investigated diseases

Chronic thromboembolic pulmonary hypertension (CTEPH) - A rare form of high blood pressure that affects the lungs and is caused by old blood clots that block or narrow the pulmonary arteries. These blockages force the heart to work harder to pump blood through the lungs, leading to increased pressure in the pulmonary arteries. Over time, the blood vessels in the lungs become damaged and thickened, making it increasingly difficult for blood to flow properly. The condition typically develops after experiencing one or more blood clots in the lungs. Patients may experience gradually worsening shortness of breath, especially during physical activity, and may also feel tired or dizzy.