Conditions: Hypertension, Pulmonary
Keywords: Pulmonary Arterial Hypertension
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 64
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether aspirin and simvastatin are safe and effective for the treatment of pulmonary arterial hypertension (PAH).

Detailed description:
PAH is characterized by dyspnea, fatigue, and lower extremity edema as a result of heart failure. In PAH, in situ thrombosis may occur in the lungs, and pulmonary endothelial dysfunction is well-recognized. As aspirin inhibits platelet aggregation, there may be value in using aspirin to treat PAH. Simvastatin has beneficial effects on blood vessels in other types of cardiovascular disease. Therefore, simvastatin may similarly benefit patients with PAH.

Participants in this study will be randomly assigned to receive 6 months of daily placebo tablets, daily aspirin and daily placebo, daily simvastatin and daily placebo, or daily aspirin and daily simvastatin in a double-blind fashion. The study will compare the safety and efficacy of aspirin to placebo and simvastatin to placebo.

Arms:
arm 1: Simvastatin: Simvastatin 40 mg, taken orally, once a day for 6 months

Aspirin: Aspirin 81 mg, taken orally, once a day for 6 months arm 2: Aspirin: Aspirin 81 mg, taken orally, once a day for 6 months

Placebo taken orally, once a day for 6 months arm 3: Placebo taken orally, once a day for 6 months

Simvastatin: Simvastatin 40 mg, taken orally, once a day for 6 months arm 4: Placebo taken orally, once a day for 6 months

Placebo taken orally, once a day for 6 months

Interventions: intervention 1: Simvastatin intervention 2: Aspirin intervention 3: Placebo
Intervention descriptions: intervention 1: Simvastatin 40 mg, taken orally, once a day for 6 months intervention 2: Aspirin 81 mg, taken orally, once a day for 6 months intervention 3: Placebo, taken orally, once a day for 6 months

Protocol document: