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
  Purpose

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
Systemic Sclerosis
Cardiac Diseases
Heart Block
Cardiac Arrhythmia
Congestive Heart Failure

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year

Resource links provided by NLM:


Further study details as provided by Second University of Naples:

Primary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 765
Study Start Date: April 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

  Eligibility

Genders Eligible for Study:   Both
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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01829126

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

Locations
France
Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016 Recruiting
Paris, France, 75014
Principal Investigator: Yannick Allanore, Prof.         
Germany
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.         
Hungary
Pecsi Tudomanyegyetem - University of Pecs Recruiting
Pecs, Hungary, H-7622
Principal Investigator: Laszlo Czirjak, Prof.         
Italy
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.         
Switzerland
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
Investigators
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:
No publications provided

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
Study First Received: April 8, 2013
Last Updated: November 7, 2013
Health Authority: Italy: Ethics Committee
Germany: Ethics Commission
Hungary: Institutional Ethics Committee
France: Institutional Ethical Committee
Switzerland: Ethikkommission
United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on October 23, 2014