Prevention of vascular damage in scleroderma with angiotensin-converting enzyme inhibitio

Completed

Conditions: Scleroderma
Musculoskeletal Diseases
Systemic connective tissue disorders

Registration Number: ISRCTN57984704

Lead Sponsor: Arthritis Research Campaign (ARC) (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Patients aged 18 years or over, and
1.1. Limited cutaneous Systemic Sclerosis (lcSSc) and Raynaud's phenomenon in which scleroderma is limited to the hands, forearms, face, lower legs and feet, or
1.2. Raynaud's phenomenon and a SSc-specific autoantibody such as anticentromere antibodies, anti-topoisomerase 1, anti-RNApolymerase antibodies, anti-ThRNP antibodies and anti-U3RNP antibodies

Exclusion Criteria

1. Known allergy to or intolerance of ACE inhibitors
2. Women of childbearing age not using reliable contraception [for example, abstinence, oral or implanted contraception, sexual partner had non-reversed vasectomy, or intra-uterine device (IUD)]
3. History of angioneurotic oedema
4. Significant impairment of renal or hepatic function
5. Severe obstructive valvular heart disease
6. Any other condition that would prevent compliance with treatment or adequate assessment

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of occurrence of new ischaemic digital ulcers.

Secondary Outcome Measures

Name	Time	Method
1. Frequency and severity of Raynaud's phenomenon<br>2. Introduction of vasodilators<br>3. Use of measures such as IV Iloprost to treat ischaemic digital lesions<br>4. Progression of scleroderma skin score<br>5. Progression of pulmonary and renal disease<br>6. Occurrence of death, significant macrovascular complications such as stroke and myocardial infarction, and pulmonary hypertension<br>7. Laboratory measures of endothelial/microvascular injury including von Willebrand factor antigen level, urinary levels of N-Acetyl-Glucosaminidase (NAG) and microalbuminuria