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Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT00984932
Recruitment Status : Completed
First Posted : September 25, 2009
Last Update Posted : September 25, 2009
Sponsor:
Information provided by:
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.


Condition or disease Intervention/treatment Phase
Systemic Sclerosis Drug: Rosuvastatin Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009


Arm Intervention/treatment
Experimental: Rosuvastatin Drug: Rosuvastatin
40 mg of rosuvastatin daily
Other Name: Statin, Crestor




Primary Outcome Measures :
  1. exercise capacity measured by the SMWT, mPAP and WHO functional class change [ Time Frame: At baseline and After 6 months of therapy ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00984932


Locations
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Egypt
Faculty of Medicine, University of Alexandria
Alexandria, Egypt, 203
Sponsors and Collaborators
University of Alexandria
Investigators
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Principal Investigator: Anna Abou-Raya University of Alexandria

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Responsible Party: Dr Anna Abou-Raya, Faculty of Medicine, University of Alexandria
ClinicalTrials.gov Identifier: NCT00984932     History of Changes
Other Study ID Numbers: alexmed116613963
First Posted: September 25, 2009    Key Record Dates
Last Update Posted: September 25, 2009
Last Verified: September 2009

Keywords provided by University of Alexandria:
systemic sclerosis
pulmonary hypertension
rosuvastatin

Additional relevant MeSH terms:
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Hypertension
Sclerosis
Hypertension, Pulmonary
Scleroderma, Systemic
Scleroderma, Diffuse
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Connective Tissue Diseases
Skin Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors