Development and Prevention of Pulmonary Hypertension in Systemic Sclerosis

April 23, 2013 updated by: Yannick ALLANORE, University of Paris 5 - Rene Descartes

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
960

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75014
        • Recruiting
        • Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016
        • Principal Investigator:
          • Yannick Allanore, Prof.
  • Germany
      • Bad Nauheim, Germany, 61231
        • Recruiting
        • Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
        • Principal Investigator:
          • Ulf Müller-Ladner, Prof.
        • Sub-Investigator:
          • Marc Frerix, Dr.
        • Sub-Investigator:
          • Ingo Tarner, Dr.
      • Berlin, Germany, 10117
        • Recruiting
        • Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie
        • Principal Investigator:
          • Gabriela Riemekasten, Prof.
      • Hamburg, Germany, 22081
        • Recruiting
        • Centre for Pediatric Rheumatology, Klinikum Eilbek
        • Principal Investigator:
          • Ivan Foeldvari, Dr.
  • Hungary
      • Pecs, Hungary, H-7622
        • Recruiting
        • Pecsi Tudomanyegyetem - University of Pecs
        • Principal Investigator:
          • Laszlo Czirjak, Prof.
  • Italy
      • Firenze, Italy, 50139
        • Recruiting
        • University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine
        • Principal Investigator:
          • Marco Matucci-Cerinic, Prof.
      • Napoli-Italia, Italy, 5-80131
        • Recruiting
        • Policlinico, Via Pansini
        • Principal Investigator:
          • Gabriele Valentini, Prof.
  • Switzerland
      • Basel, Switzerland, CH 4012 Basel
        • Recruiting
        • Felix-Platter Spital, University of Basel
        • Principal Investigator:
          • Ulrich Walker, Prof.
      • Zurich, Switzerland, 8006
        • Recruiting
        • University of Zurich, Department of Rheumatology
        • Principal Investigator:
          • Oliver Distler, Prof.
  • United Kingdom
      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital
        • Principal Investigator:
          • Francesco Del Galdo, Dr.
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • Royal Free Hospital, University College London
        • Principal Investigator:
          • Christopher Denton, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The number of patients with pulmonary hypertension at 2 years
Time Frame: 2 years
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Paris 5 - Rene Descartes

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Pecs
Charite University, Berlin, Germany
University of Zurich
University College, London
University of Leeds
University of Campania "Luigi Vanvitelli"
University of Basel
University of Giessen
University of Florence
European Union
Schoen Klinik Hamburg Eilbek

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ulf Müller-Ladner, Prof., Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
  • Principal Investigator: Yannick Allanore, Prof., Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HEALTH-F5-2012-305495-OT4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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