Development and Prevention of Severe Heart Disease in Systemic Sclerosis

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 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.

Conditions

• Systemic Sclerosis
• Cardiac Diseases
• Heart Block
• Cardiac Arrhythmia
• Congestive Heart Failure

Sponsors & Collaborators

• European Union

  collaborator OTHER

• University of Giessen

  collaborator OTHER

• University of Zurich

  collaborator OTHER

• University of Paris 5 - Rene Descartes

  collaborator OTHER

• University of Florence

  collaborator OTHER

• University of Basel

  collaborator OTHER

• University College, London

  collaborator OTHER

• Charite University, Berlin, Germany

  collaborator OTHER

• University of Pecs

  collaborator OTHER

• University of Leeds

  collaborator OTHER

• Schoen Klinik Hamburg Eilbek

  collaborator OTHER

• Gabriele Valentini

  lead OTHER

Principal Investigators

• Ulf Müller-Ladner, Prof. · Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology

• Gabriele Valentini, Prof. · Policlinico, Via Pansini, Napoli-Italia

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-04-30

Primary Completion

2016-08-31

Completion

2016-08-31

Countries

• France
• Germany
• Hungary
• Italy
• Switzerland
• United Kingdom

Study Locations