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Recruiting NCT06922240

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

Phase III Interventional Chronic Thromboembolic Pulmonary Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Riociguat, Routine Treatment.
Who it may be relevant to
Registry conditions: Chronic Thromboembolic Pulmonary Hypertension. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effect of Discontinuation of Riociguat on Right Heart Function in Patients With CTEPH After Combination Therapy

Overview

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.

Interventions

  • Drug 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.
  • Drug 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

Primary outcome measures

  • Change from Baseline in the Cardiac Output at 6 Months. [Time frame: Baseline and 6-month follow-up]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 3 centers
  • Beijing Chao-Yang Hospital — Beijing
  • China-Japan Friendship Hospital — Beijing
  • Beijing Anzhen Hospital — Beijing

Identifiers

NCT: NCT06922240 · BRWEP2024W112030108

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗