Scleroderma heart study
- Conditions
- Systemic sclerosis with heart involvementCirculatory System
- Registration Number
- ISRCTN55643149
- Lead Sponsor
- Royal Free London NHSFoundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
1. Patients with Scleroderma
2. Age 18 or older
3. Satisfied the ACR diagnostic criteria for scleroderma (also known as systemic sclerosis)
4. Suspicion of cardiac involvement from scleroderma with one of:
4.1. Left ventricular ejection fraction < 40% on echocardiogram
4.2. Abnormal heart muscle on cardiac MRI suggestive of scleroderma involvement
4.3. Diastolic heart failure in a patient without known risk factors (must satisfy: age <50, no known systemic hypertension, no diabetes mellitus, pulmonary arterial wedge pressure >15 mmHg on right heart catheterisation at rest)
4.4. Persistently raised troponin (> 2 times upper limit of normal on two occasions at least 28 days apart) without coronary artery disease
4.5. Ventricular arrythmias
5. No coronary artery disease. This needs to be excluded by CT
6. No coronary artery disease (needs to be excluded by CT coronary angiogram, myocardial perfusion scanning, dobutamine stress echocardiogram or conventional coronary angiography)
7. Able to give informed consent
1. Inability to lie flat
2. Pregnancy or breastfeeding
3. Unwilling to undergo pregnancy test prior to study (in women of child bearing potential)
4. Coronary artery disease. This needs to be excluded by CT coronary angiogram, myocardial perfusion scanning, dobutamine stress echocardiogram or conventional coronary angiogram
5. Inclusion in a clinical trial involving an investigational medical product in the last 28 days
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method