Investigational Randomized Controlled Trial of Patients with Chronic Thromboembolic Pulmonary Hypertension treated with Riociguat vs Selexipag

Not Applicable

Recruiting

• Conditions: chronic thromboembolic pulmonary hypertension; D006976

• Registration Number: JPRN-jRCT1041210122
• Lead Sponsor: Adachi Shiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. 20 years or over
2. Patients who were diagnosed with pulmonary hypertension which satisfy all the
criteria bellow
1) mean pulmonary artery pressure of 25 mmHg or over at rest
2) pulmonary artery wedge pressure or left ventricular end-diastolic pressure of
15 mmHg or under
3) pulmonary vascular resistance of 3 Wood Unit or over
3. Chronic thromboembolic pulmonary hypertension diagnosed with the use of two or more of the following imaging methods: computed tomography, ventilation/perfusion scanning, or pulmonary angiography. Additionally those satisfy either of the criteria below
1) inoperable because of occlusion of distal pulmonary arteries
2) residual pulmonary hypertension after pulmonary endarterectomy with
no operability
3) Inoperable patients estimated as high risk for surgery
4. 6-min walk test of 150m or more just before consent
5. Patients who gived signed informed consent (Informed consent could be obtained by legal representative when difficult to be obtained from the patient)

Exclusion Criteria

1) patients suspected to have an allergy to either of the drugs
2) Creatinine clearlance under 15 mL/min, or patients receiving hemodyalysis
3) Severe liver dysfunction (Child Pugh grade C)
4) pulmonary vascular obstructive disease
5) pregnancy females
6) patients receiving either of the drugs within 3 months
7) patients receiving contraindicated drugs of riociguat or selexipag as below
riociguat: nitrates or nitric oxide donors, PDE inhibitors, Azole antifungal agent, HIV protease inhibitor, Ombitasvir, paritaprevir, ritonavir, sGC stimulaters
8) patient who is very likely to recieve BPA within 20 weeks from radamization

Study & Design

• Study Type: Interventional
• Study Design: Not specified