Status:
COMPLETED
Simvastatin as a Treatment for Pulmonary Hypertension
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Medical Research Council
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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.
Detailed Description
Pulmonary arterial hypertension (PAH) is a disease that is characterised by progressive narrowing of the blood vessels of the lungs. This results in a pressure load on the heart and heart failure. Th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00180713
Start Date
October 1 2005
End Date
May 1 2009
Last Update
August 21 2019
Active Locations (3)
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1
Department of Internal Medicine II, Klinikstrasse 36 D-35392
Giessen, Germany
2
Royal Brompton Hospital, Sydney Street
London, United Kingdom, SW3 6NP
3
Hammersmith Hospital, Du Cane Road
London, United Kingdom, W12 0NN