Status:
UNKNOWN
Development and Prevention of Severe Heart Disease in Systemic Sclerosis
Lead Sponsor:
Gabriele Valentini
Collaborating Sponsors:
European Union
University of Giessen
Conditions:
Systemic Sclerosis
Cardiac Diseases
Eligibility:
All Genders
Brief Summary
Systemic sclerosis is an orphan, multiorgan disease affecting the connective tissue of the skin and all internal organs. Cardiac involvement, mainly characterised by small intramyocardial coronary art...
Eligibility Criteria
Inclusion
- Juvenile and adult systemic sclerosis patients, with diagnosis according to the SSc ACR/EULAR criteria or the PRES/ACR/EULAR juvenile SSc criteria respectively
- Asymptomatic (for cardiac disease) systemic sclerosis patients at risk for severe heart disease with at least one of the following risk factors: male sex and/or DLCO lower than 80% and/or sPAP \> 30 mmHg and/or synovitis and/or joint contractures and/or digital ulcers and/or proteinuria.
- Asymptomatic for cardiac disease is defined by patients without dyspnea NYHA \>/= II, without palpitations and without bilateral leg edema.
Exclusion
- Any significant pulmonary parenchymal (FVC \< 70% and/or DLCO \< 70%), pulmonary vascular (estimated systolic PAP \> 40 mmHg), gastrointestinal (malabsorption syndrome or paralytic ileus) or renal (serum creatinine level \>1.2 mg/dl, dialysis or previous scleroderma renal crisis) involvement
- Patients with dyspnea class NYHA \>/= II
- Patients with palpitations
- Patients with bilateral leg edema.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2016
Estimated Enrollment :
765 Patients enrolled
Trial Details
Trial ID
NCT01829126
Start Date
April 1 2013
End Date
August 1 2016
Last Update
November 8 2013
Active Locations (11)
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1
Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016
Paris, France, 75014
2
Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
Bad Nauheim, Germany, 61231
3
Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie
Berlin, Germany, 10117
4
Centre for Pediatric Rheumatology, Klinikum Eilbek
Hamburg, Germany, 22081