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Development and Prevention of Severe Heart Disease in Systemic Sclerosis

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ClinicalTrials.gov Identifier: NCT01829126
Recruitment Status : Unknown
Verified November 2013 by Gabriele Valentini, Second University of Naples.
Recruitment status was:  Recruiting
First Posted : April 11, 2013
Last Update Posted : November 8, 2013
Information provided by (Responsible Party):

Study Description
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 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.

Condition or disease
Systemic Sclerosis Cardiac Diseases Heart Block Cardiac Arrhythmia Congestive Heart Failure

Study Design

Study Type : Observational [Patient Registry]
Estimated Enrollment : 765 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Study Start Date : April 2013
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Groups and Cohorts

Patients receiving calcium channel blockers (CCB)
Patients receiving angiotensin converting enzyme inhibitors (ACEi)
CCB and ACEi
Patients receiving calcium channel blockers (CCB) and angiotensin converting enzyme inhibitors (ACEi)
No treatment
Patients not receiving calcium channel blockers (CCB) and/or angiotensin converting enzyme inhibitors (ACEi)

Outcome Measures

Primary Outcome Measures :
  1. Cumulative incidence of CB, VA, pacemaker implantation, congestive heart failure and sudden death [ Time Frame: 1 years ]
    Cumulative incidence of cardiac blocks, ventricular arrhythmias, pacemaker implantation, congestive heart failure and sudden death.

Other Outcome Measures:
  1. Incidence of drug-related adverse events, incidence of withdrawal from treatment due to drug-related adverse events [ Time Frame: 1 year ]

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population are adult and juvenile SSc patients from the EUSTAR cohort (MEDSonline database) and the jSScWG cohort

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829126

Contact: Gabriele Valentini, Prof. 39815464487 gabriele.valentini@unina2.it

Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016 Recruiting
Paris, France, 75014
Principal Investigator: Yannick Allanore, Prof.         
Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology Recruiting
Bad Nauheim, Germany, 61231
Principal Investigator: Ulf Müller-Ladner, Prof.         
Sub-Investigator: Ingo H. Tarner, Dr.         
Sub-Investigator: Marc Frerix, Dr.         
Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie Recruiting
Berlin, Germany, 10117
Principal Investigator: Gabriela Riemekasten, Prof.         
Centre for Pediatric Rheumatology, Klinikum Eilbek Recruiting
Hamburg, Germany, 22081
Principal Investigator: Ivan Foeldvari, Dr.         
Pecsi Tudomanyegyetem - University of Pecs Recruiting
Pecs, Hungary, H-7622
Principal Investigator: Laszlo Czirjak, Prof.         
University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine Recruiting
Firenze, Italy, 50139
Principal Investigator: Marco Matucci-Cerinic, Prof.         
Policlinico, Via Pansini Recruiting
Napoli-Italia, Italy, 5-80131
Principal Investigator: Gabriele Valentini, Prof.         
Felix-Platter Spital, University of Basel Recruiting
Basel, Switzerland, CH 4012
Principal Investigator: Ulrich Walker, Prof         
University of Zurich, Department of Rheumatology Recruiting
Zurich, Switzerland, 8006
Principal Investigator: Oliver Distler, Prof.         
United Kingdom
The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital Recruiting
Leeds, United Kingdom, LS9 7TF
Principal Investigator: Francesco Del Galdo, Dr.         
Royal Free Hospital, University College London Recruiting
London, United Kingdom, NW3 2QG
Principal Investigator: Christopher Denton, Prof.         
Sponsors and Collaborators
Gabriele Valentini
European Union
University of Giessen
University of Zurich
University of Paris 5 - Rene Descartes
University of Florence
University of Basel
University College, London
Charite University, Berlin, Germany
University of Pecs
University of Leeds
Schoen Klinik Hamburg Eilbek
Study Chair: Ulf Müller-Ladner, Prof. Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
Principal Investigator: Gabriele Valentini, Prof. Policlinico, Via Pansini, Napoli-Italia
More Information

Additional Information:
Responsible Party: Gabriele Valentini, Prof. Gabriele Valentini, Second University of Naples
ClinicalTrials.gov Identifier: NCT01829126     History of Changes
Other Study ID Numbers: HEALTH-F5-2012-305495-OT5
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Heart Failure
Scleroderma, Systemic
Scleroderma, Diffuse
Arrhythmias, Cardiac
Heart Diseases
Heart Block
Cardiovascular Diseases
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Enzyme Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Calcium Channel Blockers
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors
Membrane Transport Modulators