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Development and Prevention of Severe Heart Disease in Systemic Sclerosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Second University of Naples
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Gabriele Valentini, Second University of Naples
ClinicalTrials.gov Identifier:
NCT01829126
First received: April 8, 2013
Last updated: November 7, 2013
Last verified: November 2013

April 8, 2013
November 7, 2013
April 2013
August 2016   (final data collection date for primary outcome measure)
Cumulative incidence of CB, VA, pacemaker implantation, congestive heart failure and sudden death [ Time Frame: 1 years ] [ Designated as safety issue: No ]
Cumulative incidence of cardiac blocks, ventricular arrhythmias, pacemaker implantation, congestive heart failure and sudden death.
Same as current
Complete list of historical versions of study NCT01829126 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Incidence of drug-related adverse events, incidence of withdrawal from treatment due to drug-related adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
 
Development and Prevention of Severe Heart Disease in Systemic Sclerosis
Not Provided

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.

Not Provided
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
1 Year
Not Provided
Probability Sample

The study population are adult and juvenile SSc patients from the EUSTAR cohort (MEDSonline database) and the jSScWG cohort

  • Systemic Sclerosis
  • Cardiac Diseases
  • Heart Block
  • Cardiac Arrhythmia
  • Congestive Heart Failure
Not Provided
  • CCB
    Patients receiving calcium channel blockers (CCB)
  • ACEi
    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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
765
August 2016
August 2016   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact: Gabriele Valentini, Prof. 39815464487 gabriele.valentini@unina2.it
France,   Germany,   Hungary,   Italy,   Switzerland,   United Kingdom
 
NCT01829126
HEALTH-F5-2012-305495-OT5
No
Gabriele Valentini, Second University of Naples
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
Second University of Naples
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP