Simvastatin as a Treatment for Pulmonary Hypertension

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to investigate the safety and efficacy of adding simvastatin to the current conventional treatment regimen for the management of pulmonary hypertension.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College London
• Collaborator: Medical Research Council
• Treatments: Simvastatin

Criteria

Inclusion Criteria:

• Patients with idiopathic PAH or PAH related to collagen vascular disease

• Age 18 years or over

• Receiving conventional therapy with diuretics, digoxin, warfarin, sildenafil and bosentan. Stable for 1 month

• 6 minute walk distance between 150m and 450m

• Modified NYHA functional class II or III

Exclusion Criteria:

• PAH from a cause other than permitted by entry criteria

• Change in PAH treatment in past 4 weeks

• Patients requiring prostanoid therapy

• Patients already taking a statin

• Clinically significant disturbance of liver function - AST or ALT >3xULM; bilirubin >1.5xULM

• Contraindication for a magnetic resonance scan