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

JRCT ID: jRCT1041210122

Registered date:26/12/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: chronic thromboembolic pulmonary hypertension
• Date of first enrollment: 11/01/2021
• Target sample size: 20
• Study type: Interventional

Intervention(s)

Patients will be randomly allocated to riociguat treated group or selexipag treated group
with PVR as a allocated factor. Riociguat is taken up to a maximum of 2.5mg taken three times a day. Selexipag is taken up to a maximum of 1.6mg taken two times a day.

Outcome(s)

• Primary Outcome: Change in diagnostic parameters at 20 weeks compared to the baseline in both group.

Secondary Outcome

Change in the value of the factors below at 20 week compared to the baseline
1. hemodynamic indices (PVR, mPAP, CO, CI, ABP)
2. safety1): Rate of the patients who received the maximum dose of allocated drug
3. safety2): Rate of the patients who received dose of 6 mg/day or over for riociguat, dose of 2mg/day or over.
4. Rate of adverse events
5. 6-min walking test
6. WHO-FC, emPHasis 10
7. echocardiographic parameters
8. BNP

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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)

Exclude 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

Related Information

• Primary Sponsor: Adachi Shiro