Development and Prevention of Severe Heart Disease in Systemic Sclerosis

• Sponsor: Gabriele Valentini (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01829126
• Collaborator: European Union (Other), University of Giessen (Other), University of Zurich (Other), University of Paris 5 - Rene Descartes (Other), University of Florence (Other), University of Basel (Other), University College, London (Other), Charite University, Berlin, Germany (Other), University of Pecs (Other), University of Leeds (Other), Schoen Klinik Hamburg Eilbek (Other)
• Enrollment: 765
• Locations: 11
• Duration (Months): 40
• Patients Per Site: 69.5
• Patients Per Site Per Month: 1.7

Study Details

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	Intervention/Treatment	Phase
Systemic Sclerosis; Cardiac Diseases; Heart Block; Cardiac Arrhythmia; Congestive Heart Failure

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 765 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Study Start Date: Apr 1, 2013
• Anticipated Primary Completion Date: Aug 1, 2016
• Anticipated Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

1. Cumulative incidence of CB, VA, pacemaker implantation, congestive heart failure and sudden death [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 [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016	Paris		France	75014
2	Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology	Bad Nauheim		Germany	61231
3	Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie	Berlin		Germany	10117
4	Centre for Pediatric Rheumatology, Klinikum Eilbek	Hamburg		Germany	22081
5	Pecsi Tudomanyegyetem - University of Pecs	Pecs		Hungary	H-7622
6	University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine	Firenze		Italy	50139
7	Policlinico, Via Pansini	Napoli-Italia		Italy	5-80131
8	Felix-Platter Spital, University of Basel	Basel		Switzerland	CH 4012
9	University of Zurich, Department of Rheumatology	Zurich		Switzerland	8006
10	The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital	Leeds		United Kingdom	LS9 7TF
11	Royal Free Hospital, University College London	London		United Kingdom	NW3 2QG

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gabriele Valentini, Prof. Gabriele Valentini, University of Campania "Luigi Vanvitelli"
• ClinicalTrials.gov Identifier: NCT01829126
• Other Study ID Numbers: HEALTH-F5-2012-305495-OT5
• First Posted: Apr 11, 2013
• Last Update Posted: Nov 8, 2013
• Last Verified: Nov 1, 2013

• Additional relevant MeSH terms: Heart Failure; Arrhythmias, Cardiac; Heart Diseases; Heart Block; Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis

Study Results

No Results Posted as of Nov 8, 2013