Riociguat-Discontinue Effects on Right HEART in CTEPH (RED-HEART)
NCT ID: NCT06922240
Last Updated: 2025-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
68 participants
INTERVENTIONAL
2025-03-21
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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riociguat group
The subject was given comprehensive treatment in accordance with the guidelines and oral riociguat.
Riociguat
On the basis of the comprehensive treatment in line with the guidelines, including conventional diuresis, anticoagulation, oxygen inhalation, etc., continue oral administration of riociguat for treatment.
routine treatment group
The subject was given comprehensive treatment in accordance with the guidelines.
Routine Treatment
On the basis of the comprehensive treatment in line with the guidelines, including conventional diuresis, anticoagulation, oxygen inhalation, etc, and stop taking riociguat
Interventions
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Riociguat
On the basis of the comprehensive treatment in line with the guidelines, including conventional diuresis, anticoagulation, oxygen inhalation, etc., continue oral administration of riociguat for treatment.
Routine Treatment
On the basis of the comprehensive treatment in line with the guidelines, including conventional diuresis, anticoagulation, oxygen inhalation, etc, and stop taking riociguat
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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China-Japan Friendship Hospital
OTHER
Beijing Anzhen Hospital
OTHER
Suqiao Yang
OTHER
Responsible Party
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Suqiao Yang
professor
Locations
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Beijing Chao-Yang Hospital
Beijing, China, China
China-Japan Friendship Hospital
Beijing, China, China
Beijing Anzhen Hospital
Beijing, China, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BRWEP2024W112030108
Identifier Type: -
Identifier Source: org_study_id
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