Simvastatin as a Treatment for Pulmonary Hypertension
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|ClinicalTrials.gov Identifier: NCT00180713|
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : August 21, 2019
Last Update Posted : August 21, 2019
|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|
|Actual Study Start Date :||October 2005|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||May 2009|
Placebo Comparator: Arm 1: Control
Placebo tablet once daily
Placebo tablet once daily.
Experimental: Arm 2: Experimental
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
- Change in Right Ventricular Mass From Baseline [ Time Frame: 6 months post study treatment ]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)
- Change in 6-minute Walk Distance [ Time Frame: 6 months ]Change in distance achieved in 6 minute walk test from baseline
- Change in LV Mass [ Time Frame: 6 months ]Change in LV mass from baseline based on cardiac MRI
- Circulating Levels of BNP [ Time Frame: 6 months ]Change in NT-proBNP levels compared to baseline
- Change in Quality of Life Score [ Time Frame: 6 months ]Change in quality of life score from baseline as measured by Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) scored from 1-25, with higher scores indicating worse quality of life, the investigator reported the score change.
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|
|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|