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Development and Prevention of Pulmonary Hypertension in Systemic Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01840748
Recruitment Status : Unknown
Verified April 2013 by Yannick ALLANORE, University of Paris 5 - Rene Descartes.
Recruitment status was:  Recruiting
First Posted : April 26, 2013
Last Update Posted : April 26, 2013
Sponsor:
Collaborators:
European Union
University of Giessen
University of Zurich
University of Florence
University of Campania "Luigi Vanvitelli"
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):
Yannick ALLANORE, University of Paris 5 - Rene Descartes

Brief 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.


Condition or disease
Systemic Sclerosis Pulmonary Hypertension

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 960 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Study Start Date : April 2013
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017


Group/Cohort
no vasodilator
patients receiving no vasodilator
CCB
patients receiving a calcium channel blocker (CCB) for digital vasculopathy
i.v. prostanoids or PDE5i or ETRAs
patients treated with i.v. prostanoids or phosphodiesterase-5 inhibitors (PDE5i) or endothelin receptor antagonists (ETRA), regardless of whether a calcium channel blocker is given in addition



Primary Outcome Measures :
  1. The number of patients with pulmonary hypertension at 2 years [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Time to development of precapillary pulmonary hypertension [ Time Frame: 2 years ]
    participants will be followed for the duration of 2 years, the time until development of precapillary pulmonary hypertension is the secondary outcome



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population are adult and juvenile systemic sclerosis patients from the EUSTAR cohort (MEDSonline database) and the juvenile systemic sclerosis working group cohort
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840748


Contacts
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Contact: Yannick Allanore, Prof. yannick.allanore@cch.aphp.fr
Contact: Jérome Avouac, Prof. javouac@yahoo.fr

Locations
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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 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 Basel
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
University of Paris 5 - Rene Descartes
European Union
University of Giessen
University of Zurich
University of Florence
University of Campania "Luigi Vanvitelli"
University of Basel
University College, London
Charite University, Berlin, Germany
University of Pecs
University of Leeds
Schoen Klinik Hamburg Eilbek
Investigators
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Principal Investigator: Yannick Allanore, Prof. Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016
Study Chair: Ulf Müller-Ladner, Prof. Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology

Additional Information:
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Responsible Party: Yannick ALLANORE, Prof. Yannik Allanore, University of Paris 5 - Rene Descartes
ClinicalTrials.gov Identifier: NCT01840748    
Other Study ID Numbers: HEALTH-F5-2012-305495-OT4
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: April 26, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Connective Tissue Diseases
Skin Diseases