Systemic sclerosis with heart involvement Circulatory System Systemic sclerosis with heart involvement
Conditions
Interventions
All patients will be recruited at the Scleroderma centre and National Pulmonary Hypertension Service at the Royal Free Hospital.
Pre-treatment Evaluation
Patients with
follow up visits are approximately 1-6 monthly depending on the clinical scenario. The Cardiac Evaluation includes rheumatic and cardiac history and examination, blood tests including autoantibodies,
Sponsors
Royal Free London NHSFoundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Uptake of 18FDG-PET-CT in the heart in patients with known cardiac scleroderma is assessed by PET-CT scanning at baseline and 6-9 months 2. Degree and pattern of uptake with echocardiography, cardiac markers, cardiac MRI 3. Prognosis in patients with “active” disease on 18FDG-PET-CT to those with “inactive” disease | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Degree and pattern of uptake with echocardiography, cardiac markers and cardiac biopsy findings 2. Level of uptake of 18FDG-PET in other organs known to be involved by scleroderma 3. Change in cardiac 18FDG-PET-CT in patients with “active” disease after completion of therapy 4. 18FDG-PET uptake in the lungs with dedicated pulmonary CT imaging (where available) | — |
Countries
England, United Kingdom
Contacts
Public ContactIvy Wanjiku
Outcome results
None listed