Development and Prevention of Pulmonary Hypertension in Systemic Sclerosis

Pulmonary Hypertension Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01840748
• Other study ID #: HEALTH-F5-2012-305495-OT4
• Status: Recruiting
• Phase: N/A
• First received: April 19, 2013
• Last updated: April 23, 2013
• Start date: April 2013
• Est. completion date: June 2017

Study information

• Verified date: April 2013
• Source: University of Paris 5 - Rene Descartes
• Contact: Yannick Allanore, Prof.
• Email: yannick.allanore[@]cch.aphp.fr
• 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 (SSc) is an orphan, multiorgan disease affecting the connective tissue of the skin and several internal organs.

Pulmonary hypertension (PH) is a fatal disorder characterized by an increase in pulmonary vascular resistance, which leads to right ventricular failure. Despite being recently the object of greater attention and despite therapeutic advances, pulmonary hypertension due to SSc remains associated with a dismal 47 - 67% 3-year survival. Among SSc patients prospectively followed in the "European League Against Rheumatism Scleroderma Trials and Research" (EUSTAR) cohort, 26% of death was related to pulmonary hypertension. Although some previous data have suggested the protective effects of calcium channel blockers on the development of pulmonary hypertension, the potential preventive effects of vasodilators for the prevention of Pulmonary hypertension have not been determined yet. In addition to be considered routinely for the treatment of SSc-related pulmonary hypertension, prostanoids, endothelin receptor antagonists (ETRA) and Phosphodiesterase-5 inhibitors (PDE5i) can also be used for this indication.

This observational trial is one out of five observational trials of the collaborative project "To decipher the optimal management of systemic sclerosis" (DeSScipher).

Aim of this observational trial is:

• to compare the outcomes of adult and juvenile SSc patients who are at high risk of developing pulmonary hypertension and are receiving either different vasodilator treatments or no vasodilator treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 960
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• 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 ACR/EULAR adult SSc criteria and PRES/ACR/EULAR juvenile SSc criteria respectively

• Patients at high risk of pulmonary hypertension with a Cochin Risk prediction score >/= 3

ACR = American College of Rheumatology; EULAR = European League Against Rheumatism; PRES = Pediatric Rheumatology European Society

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension
• 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
University of Paris 5 - Rene Descartes	Charite University, Berlin, Germany, European Union, Schoen Klinik Hamburg Eilbek, Second University of Naples, University College, London, University of Basel, University of Florence, University of Giessen, University of Leeds, 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
Primary	The number of patients with pulmonary hypertension at 2 years		2 years	No
Secondary	Time to development of precapillary pulmonary hypertension	participants will be followed for the duration of 2 years, the time until development of precapillary pulmonary hypertension is the secondary outcome	2 years	No

External Links

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