- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00984932
Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary Hypertension
The Effect of Rosuvastatin on Vascular Dysfunction and Inflammatory Markers in Systemic Sclerosis-related Pulmonary Hypertension: Randomized, Double-Blind Placebo-Controlled Trial
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.
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Alexandria, Egypt, 203
- Faculty of Medicine, University of Alexandria
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rosuvastatin
|
40 mg of rosuvastatin daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
exercise capacity measured by the SMWT, mPAP and WHO functional class change
Time Frame: At baseline and After 6 months of therapy
|
At baseline and After 6 months of therapy
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anna Abou-Raya, University of Alexandria
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Connective Tissue Diseases
- Sclerosis
- Hypertension
- Scleroderma, Systemic
- Scleroderma, Diffuse
- Hypertension, Pulmonary
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Rosuvastatin Calcium
Other Study ID Numbers
- alexmed116613963
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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