Effects of dual initial combination therapy with macitentan plus riociguat or macitentan plus selexipag on hemodynamics in patients with pulmonary arterial hypertension

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000035389
• Date of registration: 01/04/2019
• Prospective Registration: Yes
• Primary sponsor: Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science
• Public title: Effects of dual initial combination therapy with macitentan plus riociguat or macitentan plus selexipag on hemodynamics in patients with pulmonary arterial hypertension
• Scientific title: Effects of dual initial combination therapy with macitentan plus riociguat or macitentan plus selexipag on hemodynamics in patients with pulmonary arterial hypertension - SETOUCHI PH study
• Date of first enrolment: 2019/04/01
• Target sample size: 76
• Recruitment status: Recruiting
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039915
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Not selected

Countries of recruitment

Japan

Contacts

• Name: Kazufumi Nakamura
• Affiliation: Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science Department of Cardiovascular Medicine

• Name: Satoshi Akagi
• Affiliation: Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science Department of Cardiovascular Medicine

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1) Patients without PAH 2) Patients treated with PAH-specific drugs 3) Patients treated with incompatible drug combination 4) Patients with bleeding or risk of bleeding 5) Patients with pregnancy or suspected pregnancy or patients with breast-feeding 6) Patients with atrial fibrillation 7) Patients with moderate renal dysfunction (serum creatinine 1.5 mg/dl) 8) Patients with moderate liver dysfunction (serum AST or ALT 2-fold of standard value)9) Patients with hypotension (systolic blood pressure less than 90 mmHg) 10) Patients with low cardiac output (cardiac index less than 2.0 l/min/m2 11) Patients included other clinical study 12) Patients recognized as inappropriate by attending physician

Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Pulmonary arterial hypertension

Intervention(s)

Dose: macitentan 10 mg/day+riociguat 3 mg/day. Max dose of riociguat is 7.5 mg/day.Intervention period: 8 month
Dose: macitentan 10 mg/day+selexipag 0.4 mg/day. Max dose of selexipag is 3.2 mg/day. Intervention period: 8 month

Primary Outcome(s)

Comparison of change ratio of pulmonary vascular resistance eight month after the administration between two groups

Source(s) of Monetary Support

Self funding

Ethics review

Status: YES
Approval date: 15/01/2019
Contact:

[e-mail]

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee

086-235-6938

[e-mail]

Results

• Results available: Yes
• Date Completed: 31/03/2029