Effects of phosphodiesterase V (sildenafil) on pulmonary arterial hypertension

UMIN ID: C000000340

Registered date:01/03/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Pulmonary arterial hypertension
• Date of first enrollment: 2007/01/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Treatment with sildenafil 25mg three times daily for 24 weeks
Treatment with prior therapy without sildenafil for 24 weeks

Outcome(s)

• Primary Outcome: Decrease in pulmonary arterial pressure, pulmonary vascular resistance and increase in cardiac output at 24 weeks after allocation of patients
• Secondary Outcome: Improvement of exercise tolerance (anaerobic threshold and peak VO2) assessed by cardiopulmonary exercise testing

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1. Patients with PCWP>15mmHg 2. Pregnat women or women of childbearing potential or brestfeeding 3. Patients who are being treated with medicines that contain nitrates 4. Patients who are being treated with phosphodiesterase inhibitors other than sildenafil 5. Patients who are otherwise judged inappropriate for inclusion in the study by the investigators

Related Information

• Primary Sponsor: Division of cardiovascular internal medicine, The University of Tokyo Hospital
• Source(s) of Monetary Support: Division of cardiovascular internal medicine, The University of Tokyo Hospital