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Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary Hypertension

Primary Purpose

Systemic Sclerosis

Status

Completed

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

Rosuvastatin

About this trial

This is an interventional treatment trial for Systemic Sclerosis focused on measuring systemic sclerosis, pulmonary hypertension, rosuvastatin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Faculty of Medicine, University of Alexandria

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rosuvastatin

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00984932

First Posted

September 24, 2009

Last Updated

September 24, 2009

Sponsor

University of Alexandria

1. Study Identification

Unique Protocol Identification Number

NCT00984932

Brief Title

Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary Hypertension

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 Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Alexandria

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Sclerosis

Keywords

systemic sclerosis, pulmonary hypertension, rosuvastatin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rosuvastatin

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Rosuvastatin

Other Intervention Name(s)

Statin, Crestor

Intervention Description

40 mg of rosuvastatin daily

Primary Outcome Measure Information:

Title

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

Time Frame

At baseline and After 6 months of therapy

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anna Abou-Raya

Organizational Affiliation

University of Alexandria

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Medicine, University of Alexandria

City

Alexandria

ZIP/Postal Code

203

Country

Egypt

12. IPD Sharing Statement

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Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary Hypertension

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