Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary Hypertension

University of Alexandria

Status and phase: Completed; Phase 3

Conditions: Systemic Sclerosis

Treatments: Drug: Rosuvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00984932

alexmed116613963

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 1 patient group

Rosuvastatin

Experimental group

Treatment:

Drug: Rosuvastatin