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OpenTrials
Completed

NCT Number: NCT00984932

Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary Hypertension

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Medicine, University of Alexandria

Alexandria, Alexandria Governorate, 203, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin

Drug

40 mg of rosuvastatin daily

Other names: Statin, Crestor

Primary outcomes

  1. exercise capacity measured by the SMWT, mPAP and WHO functional class change

    Time frame: At baseline and After 6 months of therapy

Sponsors and collaborators

Lead sponsor

University of Alexandria

Other

Registry information

Official study title

The Effect of Rosuvastatin on Vascular Dysfunction and Inflammatory Markers in Systemic Sclerosis-related Pulmonary Hypertension: Randomized, Double-Blind Placebo-Controlled Trial

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 25, 2009
Registry last updated
Sep 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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