Simvastatin as a Treatment for Pulmonary Hypertension
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00180713|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : June 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension||Drug: Simvastatin Drug: Placebo||Phase 1 Phase 2|
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.
The narrowing is in part due to constriction but mostly due to structural changes in affected vessels. The structural changes affect all cell components of the vessel wall (the endothelial lining, the muscle layer and fibrous tissue) and can lead to local clot formation. In addition there is evidence of inflammation of the vessels and what is known as oxidative stress. The disease may occur with no obvious cause, when it is known as idiopathic, but it can also be associated with a variety of other diseases, including congenital heart disease, collagen vascular disease and HIV infection.
Current approaches to the treatment of pulmonary hypertension are unsatisfactory as they do not prevent disease progression and do not directly or adequately address many of the processes detailed above. Alternative or additional treatments are therefore required and an attrative approach is to use a statin (a 3-hydroxy-3-methylglutaryl-coenzymeA, or HMG-CoA, reductase inhibitor). Statins are widely used for their ability to lower blood cholesterol but increasing evidence indicates that these drugs also have direct effects on cell components of the vessel wall - including inhibiting inflammation, clot formation and oxidative stress - that might be beneficial in pulmonary hypertension.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Simvastatin as a Treatment for Pulmonary Hypertension|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||May 2009|
Placebo Comparator: 1
Placebo tablet once daily
Placebo tablet once daily.
Simvastatin 40mg od for 1 month, then uptitrated to 80mg od for 11 months.
Simvastatin 40mg od for 1 month, then 80mg od for 11 months
Other Name: Zocor
- Right ventricular mass as measured by cardiac magnetic resonance (the study is powered to detect an 8.5g difference in RV mass between the two treatments, based on reproducibility measurements of RV mass in healthy volunteers and patients) [ Time Frame: 6 months, 12 months ]
- 6-minute walk distance [ Time Frame: 6 months, 12 months ]
- LV systolic eccentricity index, tie index and right atrial area as measured by echocardiography [ Time Frame: 6 months, 12 months ]
- Circulating levels of BNP and inflammatory markers (e.g. MCP-1) [ Time Frame: 6 months, 12 months ]
- Urinary iPF 2 alpha III levels [ Time Frame: 6 months, 12 months ]
- Occurrence of adverse effects (total and severe, symptomatic and biochemical) [ Time Frame: 6 months, 12 months ]
- Quality of life (as measured by CAMPHOR) [ Time Frame: 6 months, 12 months ]
- Cardiac output and measures of RV function as measured by cardiac magnetic resonance [ Time Frame: 6 months, 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00180713
|Department of Internal Medicine II|
|Klinikstrasse 36 D-35392 Giessen, Germany|
|Royal Brompton Hospital, Sydney Street|
|London, United Kingdom, SW3 6NP|
|Hammersmith Hospital, Du Cane Road|
|London, United Kingdom, W12 0NN|
|Principal Investigator:||Martin Wilkins, MD FRCP||Imperial College London|