Development and Prevention of Severe Heart Disease in Systemic Sclerosis
NCT ID: NCT01829126
Last Updated: 2013-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
765 participants
OBSERVATIONAL
2013-04-30
2016-08-31
Brief Summary
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This observational trial is part of the collaborative project "DeSScipher", one out of five observational trials to decipher the optimal management of systemic sclerosis. Aim of this observational trial is to assess the efficacy and safety of calcium channel blockers and angiotensin converting enzyme inhibitors in asymptomatic SSc patients with cardiac involvement.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CCB
Patients receiving calcium channel blockers (CCB)
No interventions assigned to this group
ACEi
Patients receiving angiotensin converting enzyme inhibitors (ACEi)
No interventions assigned to this group
CCB and ACEi
Patients receiving calcium channel blockers (CCB) and angiotensin converting enzyme inhibitors (ACEi)
No interventions assigned to this group
No treatment
Patients not receiving calcium channel blockers (CCB) and/or angiotensin converting enzyme inhibitors (ACEi)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Patients with dyspnea class NYHA \>/= II
* Patients with palpitations
* Patients with bilateral leg edema.
ALL
No
Sponsors
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European Union
OTHER
University of Giessen
OTHER
University of Zurich
OTHER
University of Paris 5 - Rene Descartes
OTHER
University of Florence
OTHER
University of Basel
OTHER
University College, London
OTHER
Charite University, Berlin, Germany
OTHER
University of Pecs
OTHER
University of Leeds
OTHER
Schoen Klinik Hamburg Eilbek
OTHER
Gabriele Valentini
OTHER
Responsible Party
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Gabriele Valentini
Prof. Gabriele Valentini
Principal Investigators
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Ulf Müller-Ladner, Prof.
Role: STUDY_CHAIR
Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
Gabriele Valentini, Prof.
Role: PRINCIPAL_INVESTIGATOR
Policlinico, Via Pansini, Napoli-Italia
Locations
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Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016
Paris, , France
Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
Bad Nauheim, , Germany
Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie
Berlin, , Germany
Centre for Pediatric Rheumatology, Klinikum Eilbek
Hamburg, , Germany
Pecsi Tudomanyegyetem - University of Pecs
Pécs, , Hungary
University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine
Florence, , Italy
Policlinico, Via Pansini
Napoli-Italia, , Italy
Felix-Platter Spital, University of Basel
Basel, , Switzerland
University of Zurich, Department of Rheumatology
Zurich, , Switzerland
The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital
Leeds, , United Kingdom
Royal Free Hospital, University College London
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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HEALTH-F5-2012-305495-OT5
Identifier Type: -
Identifier Source: org_study_id