NCT01829126|Unknown
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Sponsor study identifier
observational
765
6 countries
11
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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 artery involvement and myocardial fibrosis, can cause the development of impaired diastolic ventricular filling, cardiac blocks and ventricular arrhythmias, and can ensue in congestive heart failure and sudden death. Until now, no drug has been proven to have a therapeutic effect on SSc myocardial disease on an evidence-based level. Short-term trials and retrospective studies have suggested a favourable and protective effect of calcium channel blockers and angiotensin converting enzyme inhibitors in patients with myocardial involvement. However, no data are presently available on the prevention and treatment of severe heart disease. 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
April 8, 2013
Actual (reported)April 11, 2013
Actual (reported)August 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Cumulative incidence of CB, VA, pacemaker implantation, congestive heart failure and sudden death
Cumulative incidence of cardiac blocks, ventricular arrhythmias, pacemaker implantation, congestive heart failure and sudden death.
1 years
Incidence of drug-related adverse events, incidence of withdrawal from treatment due to drug-related adverse events
1 year
Patients receiving calcium channel blockers (CCB)
Patients receiving angiotensin converting enzyme inhibitors (ACEi)
Patients receiving calcium channel blockers (CCB) and angiotensin converting enzyme inhibitors (ACEi)
Patients not receiving calcium channel blockers (CCB) and/or angiotensin converting enzyme inhibitors (ACEi)
The study population are adult and juvenile SSc patients from the EUSTAR cohort (MEDSonline database) and the jSScWG cohort
Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016
Paris, 75014, France
Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
Bad Nauheim, 61231, Germany
Ulf Müller-Ladner, Prof.
Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
Gabriele Valentini, Prof.
Policlinico, Via Pansini, Napoli-Italia
First Submitted
April 8, 2013
First Posted
April 11, 2013
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2016
Proof of Biological Activity of SAR100842 in Systemic Sclerosis
Contact the study team to confirm eligibility.
Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie
Berlin, 10117, Germany
Centre for Pediatric Rheumatology, Klinikum Eilbek
Hamburg, 22081, Germany
Pecsi Tudomanyegyetem - University of Pecs
Pécs, H-7622, Hungary
University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine
Florence, 50139, Italy
Policlinico, Via Pansini
Napoli-Italia, 5-80131, Italy
Felix-Platter Spital, University of Basel
Basel, CH 4012, Switzerland
University of Zurich, Department of Rheumatology
Zurich, 8006, Switzerland
The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital
Leeds, LS9 7TF, United Kingdom
Royal Free Hospital, University College London
London, NW3 2QG, United Kingdom
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 8, 2013
Record last verified: 2013-11
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