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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00984932
Enrollment
40
Registered
2009-09-25
Start date
2008-09-30
Completion date
2009-07-31
Last updated
2009-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Sclerosis

Keywords

systemic sclerosis, pulmonary hypertension, rosuvastatin

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.

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.

Interventions

DRUGRosuvastatin

40 mg of rosuvastatin daily

Sponsors

University of Alexandria
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
exercise capacity measured by the SMWT, mPAP and WHO functional class changeAt baseline and After 6 months of therapy

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026