Chronic Thromboembolic Pulmonary HypertensionPhase 3RED-HEARTNCT06922240
Riociguat-Discontinue Effects on Right HEART in CTEPH (RED-HEART)
A Phase 3 study testing Riociguat and Routine Treatment in people with Chronic Thromboembolic Pulmonary Hypertension, run by Suqiao Yang at 3 sites in China.
Trial summary
Riociguat and balloon pulmonary angioplasty (BPA) are established standard-of-care interventions for inoperable chronic thromboembolic pulmonary hypertension (CTEPH) with comparable evidence levels. However, the optimal combined treatment strategy remains unclear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- Riociguat and Routine Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 3 sitesChina
- Study dates
- 21 Mar 2025to 31 Oct 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Beijing Chao-Yang Hospital
Beijing, China, 100020
Guangxu Liu, Dr., +861085231129, bjcyh_yjxbf@163.com
Suqiao Yang, Professor
- Recruiting
China-Japan Friendship Hospital
Beijing, China, 100029
Shuai Zhang, Dr., ＋8618501259164, shuaizhang2012@126.com
Wanmu Xie, Professor
- Recruiting
Beijing Anzhen Hospital
Beijing, China, 101118
Meng Zhang, Dr., +8613552325192, mmzhang0423@163.com
Jun Wan, Professor
About this study
Official title: Effect of Discontinuation of Riociguat on Right Heart Function in Patients With CTEPH After Combination Therapy
Riociguat and balloon pulmonary angioplasty (BPA) are established standard-of-care interventions for inoperable chronic thromboembolic pulmonary hypertension (CTEPH) with comparable evidence levels. However, the optimal combined treatment strategy remains unclear. Specifically, there is no consensus on whether riociguat should be continued long-term after achieving hemodynamic stability with BPA. Additionally, the long-term effects of riociguat discontinuation on right ventricular (RV) structure and function remain poorly characterized, particularly due to the lack of comprehensive noninvasive evaluations integrating cardiac magnetic resonance (CMR) and echocardiography. This prospective study aims to determine the hemodynamic impact of riociguat discontinuation in inoperable CTEPH patients who have achieved BPA treatment endpoints using right heart catheterization (RHC). Evaluate RV remodeling and functional changes after riociguat cessation through multimodal noninvasive imaging (CMR, echocardiography). Assess safety outcomes and identify potential rebound pulmonary hypertension or decompensated RV dysfunction associated with riociguat withdrawal.
- Being tested
- Riociguat, Routine Treatment
- Keywords
- Chronic Thromboembolic Pulmonary Hypertension, Riociguat, Right heart function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RiociguatDrug
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 TreatmentDrug
On the basis of the comprehensive treatment in line with the guidelines, including conventional diuresis, anticoagulation, oxygen inhalation, etc, and stop taking riociguat
| Study group | Role | What they receive |
|---|---|---|
| riociguat group | Active comparator | The subject was given comprehensive treatment in accordance with the guidelines and oral riociguat. Receives: Drug: Riociguat |
| routine treatment group | Experimental | The subject was given comprehensive treatment in accordance with the guidelines. Receives: Drug: Routine Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Cardiac Output at 6 Months.
Cardiac Output was measured by right heart catheterization.
Measured: Baseline and 6-month follow-up
Secondary outcomes (5)
Change from Baseline in the Pulmonary Vascular Resistance at 6 Months.
Pulmonary Vascular Resistance was measured by right heart catheterization.
Measured: Baseline and 6-month follow-up
Change from Baseline in the concentration of NT-proBNP at 6 Months.
The concentration of NTproBNP in serum was detected in pg/ml
Measured: Baseline and 6-month follow-up
Change from Baseline in the 6-minute walking distance at 6 Months.
6-minute walking distance was measured by 6-minute walking test
Measured: Baseline, 3-month follow-up, and 6-month follow-up
All-cause mortality
Observe and record All-cause mortality
Measured: From the baseline to the completion follow-up,an average of 6 months
Combined incidence of all-cause death, re-hospitalization or disability/incapacity events due to clinical exacerbation of pulmonary hypertension
Observe and record All-cause mortality, clinical exacerbation of pulmonary hypertension leading to re-hospitalization or disability/incapacity
Measured: From the baseline to the completion follow-up,an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start21 Mar 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Thromboembolic Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suqiao Yang
- Sponsor type
- University, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Beijing Anzhen Hospital
- Responsible party
- Sponsor-investigator, Suqiao Yang, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922240
- Sponsor's protocol ID
- BRWEP2024W112030108
- Acronym
- RED-HEART
- Status last verified
- Apr 2025
- First submitted
- 23 Mar 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Discontinuation of Riociguat on Right Heart Function in Patients With CTEPH After Combination Therapy
- ClinicalTrials.gov ID
- NCT06922240
- Acronym / sponsor ID
- RED-HEART / BRWEP2024W112030108
- Keywords
- Chronic Thromboembolic Pulmonary Hypertension, Riociguat, Right heart function
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Suqiao YangUniversity, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Beijing Anzhen Hospital
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Riociguat and balloon pulmonary angioplasty (BPA) are established standard-of-care interventions for inoperable chronic thromboembolic pulmonary hypertension (CTEPH) with comparable evidence levels. However, the optimal combined treatment strategy remains unclear. Specifically, there is no consensus on whether riociguat should be continued long-term after achieving hemodynamic stability with BPA. Additionally, the long-term effects of riociguat discontinuation on right ventricular (RV) structure and function remain poorly characterized, particularly due to the lack of comprehensive noninvasive evaluations integrating cardiac magnetic resonance (CMR) and echocardiography. This prospective study aims to determine the hemodynamic impact of riociguat discontinuation in inoperable CTEPH patients who have achieved BPA treatment endpoints using right heart catheterization (RHC). Evaluate RV remodeling and functional changes after riociguat cessation through multimodal noninvasive imaging (CMR, echocardiography). Assess safety outcomes and identify potential rebound pulmonary hypertension or decompensated RV dysfunction associated with riociguat withdrawal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| riociguat group | Active comparator | Drug: RiociguatThe subject was given comprehensive treatment in accordance with the guidelines and oral riociguat. |
| routine treatment group | Experimental | Drug: Routine TreatmentThe subject was given comprehensive treatment in accordance with the guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RiociguatOn 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. | Drug | riociguat group |
| Routine TreatmentOn the basis of the comprehensive treatment in line with the guidelines, including conventional diuresis, anticoagulation, oxygen inhalation, etc, and stop taking riociguat | Drug | routine treatment group |
Primary outcome
Change from Baseline in the Cardiac Output at 6 Months.
Time frame: Baseline and 6-month follow-up
Cardiac Output was measured by right heart catheterization.
5 secondary outcomes
Change from Baseline in the Pulmonary Vascular Resistance at 6 Months.
Time frame: Baseline and 6-month follow-up
Change from Baseline in the concentration of NT-proBNP at 6 Months.
Time frame: Baseline and 6-month follow-up
Change from Baseline in the 6-minute walking distance at 6 Months.
Time frame: Baseline, 3-month follow-up, and 6-month follow-up
All-cause mortality
Time frame: From the baseline to the completion follow-up,an average of 6 months
Combined incidence of all-cause death, re-hospitalization or disability/incapacity events due to clinical exacerbation of pulmonary hypertension
Time frame: From the baseline to the completion follow-up,an average of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Riociguat and Routine Treatment in people with Chronic Thromboembolic Pulmonary Hypertension, run by Suqiao Yang at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suqiao Yang (010-85231217, yangsuqiao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Cardiac Output at 6 Months. (time frame: Baseline and 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.