THERAPY-HYBRID-BPA Trial

• Status: Recruiting
• Trial end date: 2025-01-28
• Target enrollment: 0
• Participant gender: All

Summary

Riociguat could improve the exercise capacity and residual symptoms in patients with chronic thromboembolic pulmonary hypertension (CTEPH) even after normalization of pulmonary arterial pressure by balloon pulmonary angioplasty (BPA). This randomized controlled trial study aimed to clarify whether the improvement of peak cardiac index (CI) during exercise maintains or not between the riociguat continued group and the riociguat discontinued group.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Hospital Organization Okayama Medical Center
• Collaborator: Bayer Yakuhin, Ltd.
• Treatments: Riociguat

Criteria

Inclusion Criteria:

1. Patients who meet CTEPH diagnostic criteria (complying with 2017 Japanese Cardiovascular Society Guidelines diagnostic criteria)

2. Patients with diagnosed as a contraindication of pulmonary endarterectomy by an experienced surgeon in the central diagnosis

3. Patients who were adjusted to reach the appropriate dose of riociguat within 8 weeks and were able to continue riociguat thereafter

4. Patients who underwent BPA once or more after the dose adjustment of riociguat

5. Patients who have been able to continue taking the same dose of riociguat for more than 3 months

6. Patients who can obtain written informed consent from the patients and legal representatives

7. Patients with WHO functional class II or III at the time of the allocation

8. Over the age of 18 and under 85 at the time of obtaining informed consent

9. Patients with the resting CI value of less than 3.0 L/min/m2 in the right heart catheterization test immediately before the allocation

10. Patients with the mean pulmonary artery pressure less than 25 mmHg in a right heart catheterization test immediately before the allocation

Exclusion Criteria:

1. Patients who are eligible for pulmonary endarterectomy (PEA)

2. Patients with pulmonary hypertension other than class 4 by NICE classification

3. Patients having difficulty in performing cardiopulmonary exercise test (CPET)

4. Patients with severe right heart failure requiring cardiotonic drugs

5. Patients with severe heart disease

6. Patients with severe liver damage

7. Patients with systolic blood pressure less than 90 mmHg at the screening

8. Patients with shunt disease

9. Patients with severe renal dysfunction (CCr < 15 mL/min) requiring hemodialysis

10. Patients with life expectancy less than 2 years

11. Being pregnant or lactating

12. Patients who are contraindicated for riociguat

13. Patients using other unlicensed drugs

14. Patients who used pulmonary vasodilators within 4 weeks after obtaining the informed consent of the right heart catheterization test.

15. Patients whom the investigator determines that the participation in this study is inappropriate