Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary Hypertension

Phase 3

Completed

• Conditions: Systemic Sclerosis
• Interventions: Drug: Rosuvastatin

• Registration Number: NCT00984932
• Lead Sponsor: University of Alexandria

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2009-09
• Study First Submitted: 2009-09-24
• Study First Submitted QC: 2009-09-24
• Last Update Submitted: 2009-09-24
• Study First Posted: 2009-09-25
• Last Update Posted: 2009-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosuvastatin	Rosuvastatin	-

Primary Outcome Measures

Name	Time	Method
exercise capacity measured by the SMWT, mPAP and WHO functional class change	At baseline and After 6 months of therapy

Trial Locations

Locations (1)

Faculty of Medicine, University of Alexandria; 🇪🇬 Alexandria, Egypt