Overview

Atorvastatin for Microvascular Endothelial Function and Raynaud in Early Diffuse Scleroderma

Status:
Completed
Trial end date:
2019-12-15
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to learn about the effect atorvastatin on blood vessel function and Raynaud symptoms in patients with early diffuse systemic sclerosis. Systemic sclerosis is a disease characterized by blood vessel injury, immune system activation and fibrosis. Blood vessel injury is thought to be important early in the disease. Blood vessel complications of systemic sclerosis include Raynaud phenomena, finger and toe ulcers, and pulmonary hypertension. While atorvastatin reduces cholesterol, it is recognized to have many effects beyond cholesterol reduction. These include improvement of blood vessel function and reduction of fibrosis. We hypothesize that treatment with atorvastatin over 16 weeks will improve blood vessel function and Raynaud symptom in patients with early diffuse systemic sclerosis. We hope that by targeting therapy early in the disease we may delay blood vessel changes and improve Raynaud symptoms.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Robyn T. Domsic, MD, MPH
University of Pittsburgh
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Treatments:
Atorvastatin
Atorvastatin Calcium
Criteria
Inclusion Criteria:

1. early diffuse scleroderma (< 3 years from the first scleroderma-related symptom)

2. Raynaud phenomenon

3. no use of lipid-lowering medication within 60 days

Exclusion Criteria:

1. pregnancy

2. renal or kidney dysfunction (creatinine < 2.0 mg/dL or creatinine clearance < 60
c/min)

3. diabetes mellitus

4. known cardiovascular disease or a prior history of stroke

5. history of liver disease

6. new or changed dose of calcium channel blockers (CCB) and angiotensin receptor
blockers (ARBs) in the last 4 weeks

7. known allergy or adverse reaction to the atorvastatin or another statin drug