Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary Hypertension
|ClinicalTrials.gov Identifier: NCT00984932|
Recruitment Status : Completed
First Posted : September 25, 2009
Last Update Posted : September 25, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Systemic Sclerosis||Drug: Rosuvastatin||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Rosuvastatin on Vascular Dysfunction and Inflammatory Markers in Systemic Sclerosis-related Pulmonary Hypertension: Randomized, Double-Blind Placebo-Controlled Trial|
|Study Start Date :||September 2008|
|Primary Completion Date :||July 2009|
|Study Completion Date :||July 2009|
U.S. FDA Resources
40 mg of rosuvastatin daily
Other Name: Statin, Crestor
- exercise capacity measured by the SMWT, mPAP and WHO functional class change [ Time Frame: At baseline and After 6 months of therapy ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00984932
|Faculty of Medicine, University of Alexandria|
|Alexandria, Egypt, 203|
|Principal Investigator:||Anna Abou-Raya||University of Alexandria|