Riociguat Versus Balloon Pulmonary Angioplasty in Non-operable Chronic thromboEmbolic Pulmonary Hypertension

NACompletedINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

January 19, 2016

Primary Completion Date

January 27, 2020

Study Completion Date

January 27, 2020

Conditions
Chronic Thromboembolic Pulmonary Hypertension
Interventions
PROCEDURE

Balloon Pulmonary Angioplasty (BPA)

Balloon pulmonary angioplasty (BPA) will be done via femoral vein. 2 sessions will be performed during the same hospitalization following by additional sessions at an interval of 2-3 weeks until a mean PAP\< 30 mmHg is achieved A pulmonary angiography and a right heart catheterization will be performed at each BPA session

DRUG

Riociguat

The starting dose will be 1 mg three times daily as recommended. The dose will be titrated every 2 weeks according to the peripheral systolic pressure. Dose should be increased by 0.5 mg three times daily every two weeks to a maximum of 2.5 mg three times daily, if systolic blood pressure is ≥95 mmHg and the patient has no signs or symptoms of hypotension.

Trial Locations (1)

94275

AP-HP, Bicêtre Hospital, Le Kremlin-Bicêtre

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT02634203 - Riociguat Versus Balloon Pulmonary Angioplasty in Non-operable Chronic thromboEmbolic Pulmonary Hypertension | Biotech Hunter | Biotech Hunter