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NCT Number: NCT06922240

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

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.

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Key information

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Anzhen Hospital, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: Baseline and 6-month follow-up

    Pulmonary Vascular Resistance was measured by right heart catheterization.

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

    Time frame: Baseline and 6-month follow-up

    The concentration of NTproBNP in serum was detected in pg/ml

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

    Time frame: Baseline, 3-month follow-up, and 6-month follow-up

    6-minute walking distance was measured by 6-minute walking test

  4. All-cause mortality

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

    Observe and record All-cause mortality

  5. 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

    Observe and record All-cause mortality, clinical exacerbation of pulmonary hypertension leading to re-hospitalization or disability/incapacity

Study contacts

Contact information is provided by the study sponsor or research team.

Suqiao Yang

CONTACT

[email protected]

010-85231217

Sponsors and collaborators

Lead sponsor

Suqiao Yang

Other

Collaborators

  • Beijing Anzhen Hospital
  • China-Japan Friendship Hospital

Registry information

Official study title

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

Acronym: RED-HEART

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 10, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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