Simvastatin as a Treatment for Pulmonary Hypertension

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2009-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pulmonary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1: Control

Placebo tablet once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet once daily.

Arm 2: Experimental

Simvastatin 40mg od for 1 month, then uptitrated to 80mg od for 11 months.

Group Type EXPERIMENTAL

Simvastatin

Intervention Type DRUG

Simvastatin 40mg od for 1 month, then 80mg od for 11 months

Interventions

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Simvastatin

Simvastatin 40mg od for 1 month, then 80mg od for 11 months

Intervention Type DRUG

Placebo

Placebo tablet once daily.

Intervention Type DRUG

Other Intervention Names

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Zocor

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No