Development and Prevention of Pulmonary Hypertension in Systemic Sclerosis
NCT ID: NCT01840748
Last Updated: 2013-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
960 participants
OBSERVATIONAL
2013-04-30
2017-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Development and Prevention of Severe Heart Disease in Systemic Sclerosis
NCT01829126
Early Diagnosis of Pulmonary Hypertension in Patients With Inflammatory Rheumatic Connective Tissue Diseases
NCT01387035
Optical Coherence Tomography Imaging in Systemic Sclerosis
NCT04532151
Treatment and Prevention of Progression of Interstitial Lung Disease in Systemic Sclerosis
NCT01858259
Early, Simple and Reliable Detection of Pulmonary Arterial Hypertension (PAH) in Systemic Sclerosis (SSc)
NCT00706082
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
no vasodilator
patients receiving no vasodilator
No interventions assigned to this group
CCB
patients receiving a calcium channel blocker (CCB) for digital vasculopathy
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
European Union
OTHER
University of Giessen
OTHER
University of Zurich
OTHER
University of Florence
OTHER
University of Campania Luigi Vanvitelli
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
University of Paris 5 - Rene Descartes
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yannick ALLANORE
Prof. Yannik Allanore
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yannick Allanore, Prof.
Role: PRINCIPAL_INVESTIGATOR
Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016
Ulf Müller-Ladner, Prof.
Role: STUDY_CHAIR
Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016
Paris, , France
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, , Germany
Pecsi Tudomanyegyetem - University of Pecs
Pécs, , Hungary
University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine
Florence, , Italy
Policlinico, Via Pansini
Napoli-Italia, , Italy
Felix-Platter Spital, University of Basel
Basel, , Switzerland
University of Zurich, Department of Rheumatology
Zurich, , Switzerland
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, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HEALTH-F5-2012-305495-OT4
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.