Systemic SclerosisNCT01840748
Development and Prevention of Pulmonary Hypertension in Systemic Sclerosis
An observational study of Systemic Sclerosis and Pulmonary Hypertension, run by University of Paris 5 - Rene Descartes at 11 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Systemic Sclerosis, Pulmonary Hypertension
- Type of treatment
- Injection or infusion
- How many people
- 960 participants
- Where
- 11 sitesin 6 countries
- Study dates
- Apr 2013to Jun 2017
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
11 sites in 6 countries.
Yannick Allanore, Prof. contact
Jérome Avouac, Prof. contact
11 sites in 6 countries
Germany3 sites, 3 recruiting
- Recruiting
Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
Bad Nauheim, 61231
Ulf Müller-Ladner, Prof.
Ingo Tarner, Dr.
- Recruiting
Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie
Berlin, 10117
Gabriela Riemekasten, Prof.
- Recruiting
Centre for Pediatric Rheumatology, Klinikum Eilbek
Hamburg, 22081
Ivan Foeldvari, Dr.
Italy2 sites, 2 recruiting
- Recruiting
University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine
Florence, 50139
Marco Matucci-Cerinic, Prof.
- Recruiting
Policlinico, Via Pansini
Napoli-Italia, 5-80131
Gabriele Valentini, Prof.
Switzerland2 sites, 2 recruiting
- Recruiting
Felix-Platter Spital, University of Basel
Basel, CH 4012 Basel
Ulrich Walker, Prof.
- Recruiting
University of Zurich, Department of Rheumatology
Zurich, 8006
Oliver Distler, Prof.
United Kingdom2 sites, 2 recruiting
- Recruiting
The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital
Leeds, LS9 7TF
Francesco Del Galdo, Dr.
- Recruiting
Royal Free Hospital, University College London
London, NW3 2QG
Christopher Denton, Prof.
France1 site, 1 recruiting
- Recruiting
Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016
Paris, 75014
Yannick Allanore, Prof.
Hungary1 site, 1 recruiting
- Recruiting
Pecsi Tudomanyegyetem - University of Pecs
Pécs, H-7622
Laszlo Czirjak, Prof.
About this study
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.
Read more
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.
- Conditions
- Systemic Sclerosis, Pulmonary Hypertension
- Medical subject headings
- Scleroderma, Systemic, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with pulmonary hypertension at 2 years
Measured: 2 years
Secondary outcomes (1)
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 960 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of Paris 5 - Rene Descartes
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Yannick ALLANORE, University of Paris 5 - Rene Descartes
- Investigators
- Yannick Allanore, Prof., Principal investigator, Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016Ulf Müller-Ladner, Prof., Study chair, Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840748
- Sponsor's protocol ID
- HEALTH-F5-2012-305495-OT4
- Status last verified
- Apr 2013
- First submitted
- 19 Apr 2013
- Last updated
- 26 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Prevention of Pulmonary Hypertension in Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT01840748
- Acronym / sponsor ID
- HEALTH-F5-2012-305495-OT4
- Conditions
- Systemic Sclerosis, Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 960 participants (estimated)
- Lead sponsor
- University of Paris 5 - Rene DescartesUniversity, hospital or other
- 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
- Study start
- Apr 2013
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 26 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The number of patients with pulmonary hypertension at 2 years
Time frame: 2 years
1 secondary outcome
Time to development of precapillary pulmonary hypertension
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yannick Allanore, Prof. contact
Jérome Avouac, Prof. contact
Yannick Allanore, Prof. principal investigator
Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016
Ulf Müller-Ladner, Prof. study chair
Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
11 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis and Pulmonary Hypertension, run by University of Paris 5 - Rene Descartes at 11 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, Italy, Switzerland, United Kingdom, France and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yannick Allanore, Prof. (yannick.allanore@cch.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients with pulmonary hypertension at 2 years (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2013.