Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-24 @ 3:45 PM
NCT ID:
NCT04600492
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04600492
Study Brief:
Protocol Section:
NCT04600492