Riociguat-Discontinue Effects on Right HEART in CTEPH (RED-HEART)

NCT06922240 | Recruiting Phase 3 DMC

• 1 other identifier: BRWEP2024W112030108
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Keywords

Chronic Thromboembolic Pulmonary Hypertension; Riociguat; Right heart function

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in the Cardiac Output at 6 Months.

  Cardiac Output was measured by right heart catheterization.

  Baseline and 6-month follow-up

Secondary Outcomes (5)

• Change from Baseline in the Pulmonary Vascular Resistance at 6 Months.

  Baseline and 6-month follow-up

• Change from Baseline in the concentration of NT-proBNP at 6 Months.

  Baseline and 6-month follow-up

• Change from Baseline in the 6-minute walking distance at 6 Months.

  Baseline, 3-month follow-up, and 6-month follow-up

• All-cause mortality

  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

  From the baseline to the completion follow-up,an average of 6 months

Study Arms (2)

riociguat group

ACTIVE COMPARATOR

The subject was given comprehensive treatment in accordance with the guidelines and oral riociguat.

Drug: Riociguat

routine treatment group

EXPERIMENTAL

The subject was given comprehensive treatment in accordance with the guidelines.

Drug: Routine Treatment

Interventions

Riociguat DRUG

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.

riociguat group

Routine Treatment DRUG

On the basis of the comprehensive treatment in line with the guidelines, including conventional diuresis, anticoagulation, oxygen inhalation, etc, and stop taking riociguat

routine treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Suqiao Yang: lead
• China-Japan Friendship Hospital: collaborator
• Beijing Anzhen Hospital: collaborator

Study Sites (3)

Beijing Chao-Yang Hospital

Beijing, China, 100020, China

RECRUITING

China-Japan Friendship Hospital

Beijing, China, 100029, China

RECRUITING

Beijing Anzhen Hospital

Beijing, China, 101118, China

RECRUITING

MeSH Terms

Interventions

riociguat

Central Study Contacts

Suqiao Yang

CONTACT

010-85231217; yangsuqiao@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: April 10, 2025
• Study Start: March 21, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)