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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSuqiao Yang

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Riociguat
  • Routine Treatment

Treatment groups

68 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Suqiao Yang

Lead sponsor

Beijing Chao Yang Hospital

Sponsor institution

China-Japan Friendship Hospital

Collaborator

Beijing Anzhen Hospital

Collaborator