Development and Prevention of Severe Heart Disease in Systemic Sclerosis

Congestive Heart Failure Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01829126
• Other study ID #: HEALTH-F5-2012-305495-OT5
• Status: Recruiting
• Phase: N/A
• First received: April 8, 2013
• Last updated: November 7, 2013
• Start date: April 2013
• Est. completion date: August 2016

Study information

• Verified date: November 2013
• Source: Second University of Naples
• Contact: Gabriele Valentini, Prof.
• Phone: 39815464487
• Email: gabriele.valentini[@]unina2.it
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeGermany: Ethics CommissionHungary: Institutional Ethics CommitteeFrance: Institutional Ethical CommitteeSwitzerland: EthikkommissionUnited Kingdom: Research Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 765
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia
• Cardiac Diseases
• Congestive Heart Failure
• Heart Block
• Heart Diseases
• Heart Failure
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Locations

Country	Name	City	State
France	Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016	Paris
Germany	Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology	Bad Nauheim
Germany	Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie	Berlin
Germany	Centre for Pediatric Rheumatology, Klinikum Eilbek	Hamburg
Hungary	Pecsi Tudomanyegyetem - University of Pecs	Pecs
Italy	University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine	Firenze
Italy	Policlinico, Via Pansini	Napoli-Italia
Switzerland	Felix-Platter Spital, University of Basel	Basel
Switzerland	University of Zurich, Department of Rheumatology	Zurich
United Kingdom	The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital	Leeds
United Kingdom	Royal Free Hospital, University College London	London

Sponsors (12)

Lead Sponsor	Collaborator
Gabriele Valentini	Charite University, Berlin, Germany, European Union, Schoen Klinik Hamburg Eilbek, University College, London, University of Basel, University of Florence, University of Giessen, University of Leeds, University of Paris 5 - Rene Descartes, University of Pecs, University of Zurich

Countries where clinical trial is conducted

France,  Germany,  Hungary,  Italy,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of drug-related adverse events, incidence of withdrawal from treatment due to drug-related adverse events		1 year	Yes
Primary	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	No

External Links

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