Development and Prevention of Severe Heart Disease in Systemic Sclerosis

NCT01829126 | Unknown

• 1 other identifier: HEALTH-F5-2012-305495-OT5
• Study Type: observational
• Target: 765
• Locations: 6 countries
• Sites: 11

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (1)

• Incidence of drug-related adverse events, incidence of withdrawal from treatment due to drug-related adverse events

  1 year

Study Arms (4)

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 Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gabriele Valentini: lead
• European Union: collaborator
• University of Giessen: collaborator
• University of Zurich: collaborator
• University of Paris 5 - Rene Descartes: collaborator
• University of Florence: collaborator
• University of Basel: collaborator
• University College, London: collaborator
• Charite University, Berlin, Germany: collaborator
• University of Pecs: collaborator
• University of Leeds: collaborator
• Schoen Klinik Hamburg Eilbek: collaborator

Study Sites (11)

Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016

Paris, 75014, France

RECRUITING

Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology

Bad Nauheim, 61231, Germany

RECRUITING

Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie

Berlin, 10117, Germany

RECRUITING

Centre for Pediatric Rheumatology, Klinikum Eilbek

Hamburg, 22081, Germany

RECRUITING

Pecsi Tudomanyegyetem - University of Pecs

Pécs, H-7622, Hungary

RECRUITING

University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine

Florence, 50139, Italy

RECRUITING

Policlinico, Via Pansini

Napoli-Italia, 5-80131, Italy

RECRUITING

Felix-Platter Spital, University of Basel

Basel, CH 4012, Switzerland

RECRUITING

University of Zurich, Department of Rheumatology

Zurich, 8006, Switzerland

RECRUITING

The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital

Leeds, LS9 7TF, United Kingdom

RECRUITING

Royal Free Hospital, University College London

London, NW3 2QG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Scleroderma, Systemic; Heart Diseases; Heart Block; Arrhythmias, Cardiac; Heart Failure

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ulf Müller-Ladner, Prof.

  Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology

  STUDY CHAIR

• Gabriele Valentini, Prof.

  Policlinico, Via Pansini, Napoli-Italia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriele Valentini, Prof.

CONTACT

39815464487; gabriele.valentini@unina2.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Gabriele Valentini

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 11, 2013
• Study Start: April 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: November 8, 2013

Record last verified: 2013-11

Locations

GB (2); FR (1); IT (2); DE (3); HU (1); CH (2)