Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary Hypertension

This study has been completed.
Sponsor:
Information provided by:
Faculty of Medicine, University of Alexandria
ClinicalTrials.gov Identifier:
NCT00984932
First received: September 24, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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 Intervention Phase
Systemic Sclerosis
Drug: Rosuvastatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Faculty of Medicine, University of Alexandria:

Primary Outcome Measures:
  • exercise capacity measured by the SMWT, mPAP and WHO functional class change [ Time Frame: At baseline and After 6 months of therapy ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: September 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rosuvastatin Drug: Rosuvastatin
40 mg of rosuvastatin daily
Other Name: Statin, Crestor

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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00984932

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

No publications provided

Responsible Party: Dr Anna Abou-Raya, Faculty of Medicine, University of Alexandria
ClinicalTrials.gov Identifier: NCT00984932     History of Changes
Other Study ID Numbers: alexmed116613963
Study First Received: September 24, 2009
Last Updated: September 24, 2009
Health Authority: Egypt: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 22, 2014