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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Riociguat
DrugOn 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
DrugOn the basis of the comprehensive treatment in line with the guidelines, including conventional diuresis, anticoagulation, oxygen inhalation, etc, and stop taking riociguat
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: riociguat groupActive comparator 1 intervention
Group B: routine treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in the Cardiac Output at 6 Months.
Cardiac Output was measured by right heart catheterization.
Time frame
Baseline and 6-month follow-upSecondary outcomes
1
Change from Baseline in the Pulmonary Vascular Resistance at 6 Months.
Pulmonary Vascular Resistance was measured by right heart catheterization.
Time frame
Baseline and 6-month follow-up2
Change from Baseline in the concentration of NT-proBNP at 6 Months.
The concentration of NTproBNP in serum was detected in pg/ml
Time frame
Baseline and 6-month follow-up3
Change from Baseline in the 6-minute walking distance at 6 Months.
6-minute walking distance was measured by 6-minute walking test
Time frame
Baseline, 3-month follow-up, and 6-month follow-up4
All-cause mortality
Observe and record All-cause mortality
Time frame
From the baseline to the completion follow-up,an average of 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Suqiao Yang
Lead sponsor
Beijing Chao Yang Hospital
Sponsor institution
China-Japan Friendship Hospital
Collaborator
Beijing Anzhen Hospital
Collaborator
Source ClinicalTrials.gov