Scleroderma Musculoskeletal Diseases Systemic connective tissue disorders
Conditions
Interventions
Patients will be randomised to quinapril (20 mg/day) or placebo. The dose will be increased by 20 mg every 2 weeks to a maximum dose of 80 mg/day. Treatment will be for 3 years.
Sponsors
Arthritis Research Campaign (ARC) (UK)
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of occurrence of new ischaemic digital ulcers. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Frequency and severity of Raynaud's phenomenon 2. Introduction of vasodilators 3. Use of measures such as IV Iloprost to treat ischaemic digital lesions 4. Progression of scleroderma skin score 5. Progression of pulmonary and renal disease 6. Occurrence of death, significant macrovascular complications such as stroke and myocardial infarction, and pulmonary hypertension 7. Laboratory measures of endothelial/microvascular injury including von Willebrand factor antigen level, urinary levels of N-Acetyl-Glucosaminidase (NAG) and microalbuminuria | — |
Countries
United Kingdom
Outcome results
None listed