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Investigational Randomized Controlled Trial of Patients with Chronic Thromboembolic Pulmonary Hypertensiontreated with Riociguat vs Selexipag (RISE-CTEPH study)

Investigational Randomized Controlled Trial of Patients with Chronic Thromboembolic Pulmonary Hypertension treated with Riociguat vs Selexipag (RISE-CTEPH study)

Adachi Shiro

Nagoya University Hospital

65 Tsurumai-cho, Showa-ku, Nagoya, Aichi

sadachi@med.nagoya-u.ac.jp

Nakano Yoshihisa

Nagoya University Graduate School of Medicine

65 Tsurumai-cho, Showa-ku, Nagoya, Aichi

+81-52-744-2150

middlefield0608@med.nagoya-u.ac.jp

Recruiting

Dec. 26, 2021

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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)

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

Both

chronic thromboembolic pulmonary hypertension

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.

chronic thromboembolic pulmonary hypertension

randomized controll trial

D006976

D016449

Change in diagnostic parameters at 20 weeks compared to the baseline in both group.

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

+81-52-744-2479

Dec. 08, 2021

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