Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary Hypertension

Study Overview
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Brief Summary
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Although the aetiology of SSc-PAH remains elusive, vascular dysfunction seems to be the initial event and statins through their vasculoprotective effect might be of value in the treatment armamentarium of PAH related to SSc. The aim was to assess the efficacy of rosuvastatin in ameliorating vascular dysfunction and in the management of SSc-related PAH.

Detailed Description
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Background: Pulmonary arterial hypertension (PAH) is an acknowledged devastating complication of systemic sclerosis (SSc); difficult to manage with a poor prognosis. Although the aetiology of SSc-PAH remains elusive, vascular dysfunction seems to be the initial event. Statins, through their pleotropic effects might be of value in the treatment armamentarium of PAH related to SSc. Objectives: The aim was to assess the efficacy of rosuvastatin in ameliorating vascular dysfunction and in the management of SSc-related PAH. Methods: Forty SSc patients fulfilling the ACR criteria for the classification of SSc diagnosis and having PAH were recruited. All SSc patients underwent transthoracic echocardiography and the six minute walk test (SMWT). Patients were randomized into 2 groups; the first group (n = 23) were assigned to receive 40mg of rosuvastatin and the second group (n = 23) received placebo for 6 months. The levels of endothelial dysfunction and inflammatory markers were assayed at baseline and after 6 months of therapy. Outcome measures assessed included exercise capacity (SMWT), MPAP, WHO functional class change, tolerability and safety.

Official Title
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The Effect of Rosuvastatin on Vascular Dysfunction and Inflammatory Markers in Systemic Sclerosis-related Pulmonary Hypertension: Randomized, Double-Blind Placebo-Controlled Trial

Conditions
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Systemic Sclerosis

Intervention / Treatment
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* Drug: Rosuvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: New York Heart Association (NYHA) class III A mean pulmonary artery pressure (mPAP) of > 30mmHg at rest Exclusion Criteria: Smoking Diabetes mellitus Hypercholesterolemia Hypertension Cardiac insufficiency Coexisting hepatic and renal diseases Use of drugs known to interact with statins. Patients with severe interstitial lung fibrosis
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosuvastatin<br> | Drug: Rosuvastatin<br>* 40 mg of rosuvastatin daily<br>* Other names: Statin, Crestor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exercise capacity measured by the SMWT, mPAP and WHO functional class change |  | At baseline and After 6 months of therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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systemic sclerosis, pulmonary hypertension, rosuvastatin