Systemic SclerosisNCT01829126
Development and Prevention of Severe Heart Disease in Systemic Sclerosis
An observational study of Systemic Sclerosis and Cardiac Diseases, run by Gabriele Valentini at 11 sites in 6 countries.
Trial summary
Systemic sclerosis is an orphan, multiorgan disease affecting the connective tissue of the skin and all internal organs. Cardiac involvement, mainly characterised by small intramyocardial coronary artery involvement and myocardial fibrosis, can cause the development of impaired diastolic ventricular filling, cardiac… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Systemic Sclerosis, Cardiac Diseases, Heart Block
- How many people
- 765 participants
- Where
- 11 sitesin 6 countries
- Study dates
- Apr 2013to Aug 2016
- How long will I take part?
- 1 Year
- 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 SSc patients from the EUSTAR cohort (MEDSonline database) and the jSScWG cohort
Who may be able to join
- Juvenile and adult systemic sclerosis patients, with diagnosis according to the SSc ACR/EULAR criteria or the PRES/ACR/EULAR juvenile SSc criteria respectively
- Asymptomatic (for cardiac disease) systemic sclerosis patients at risk for severe heart disease with at least one of the following risk factors: male sex and/or DLCO lower than 80% and/or sPAP > 30 mmHg and/or synovitis and/or joint contractures and/or digital ulcers and/or proteinuria.
- Asymptomatic for cardiac disease is defined by patients without dyspnea NYHA >/= II, without palpitations and without bilateral leg edema.
Who cannot join
- Any significant pulmonary parenchymal (FVC < 70% and/or DLCO < 70%), pulmonary vascular (estimated systolic PAP > 40 mmHg), gastrointestinal (malabsorption syndrome or paralytic ileus) or renal (serum creatinine level >1.2 mg/dl, dialysis or previous scleroderma renal crisis) involvement
- Patients with dyspnea class NYHA >/= II
- Patients with palpitations
- Patients with bilateral leg edema.
Trial locations and contacts
11 sites in 6 countries.
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 H. 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
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 is an orphan, multiorgan disease affecting the connective tissue of the skin and all internal organs. Cardiac involvement, mainly characterised by small intramyocardial coronary artery involvement and myocardial fibrosis, can cause the development of impaired diastolic ventricular filling, cardiac blocks and ventricular arrhythmias, and can ensue in congestive heart failure and sudden death. Until now, no drug has been proven to have a therapeutic effect on SSc myocardial disease on an evidence-based level. Short-term trials and retrospective studies have suggested a favourable and protective effect of calcium channel blockers and angiotensin converting enzyme inhibitors in patients with myocardial involvement. However, no data are presently available on the prevention and treatment of severe heart disease.
This observational trial is part of the collaborative project "DeSScipher", one out of five observational trials to decipher the optimal management of systemic sclerosis. Aim of this observational trial is to assess the efficacy and safety of calcium channel blockers and angiotensin converting enzyme inhibitors in asymptomatic SSc patients with cardiac involvement.
- Conditions
- Systemic Sclerosis, Cardiac Diseases, Heart Block, Cardiac Arrhythmia, Congestive Heart Failure
- Medical subject headings
- Scleroderma, Systemic, Heart Diseases, Heart Block, Arrhythmias, Cardiac, Heart Failure
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 |
|---|---|---|
| CCB | Patients receiving calcium channel blockers (CCB) | |
| ACEi | Patients receiving angiotensin converting enzyme inhibitors (ACEi) | |
| CCB and ACEi | Patients receiving calcium channel blockers (CCB) and angiotensin converting enzyme inhibitors (ACEi) | |
| No treatment | Patients not receiving calcium channel blockers (CCB) and/or angiotensin converting enzyme inhibitors (ACEi) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of CB, VA, pacemaker implantation, congestive heart failure and sudden death
Cumulative incidence of cardiac blocks, ventricular arrhythmias, pacemaker implantation, congestive heart failure and sudden death.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (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
- 765 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Gabriele Valentini
- Sponsor type
- University, hospital or other
- Collaborators
- European Union, University of Giessen, University of Zurich, University of Paris 5 - Rene Descartes, University of Florence, University of Basel, University College, London, Charite University, Berlin, Germany, University of Pecs, University of Leeds, Schoen Klinik Hamburg Eilbek
- Responsible party
- Sponsor-investigator, Gabriele Valentini, University of Campania Luigi Vanvitelli
- Investigators
- Ulf Müller-Ladner, Prof., Study chair, Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical ImmunologyGabriele Valentini, Prof., Principal investigator, Policlinico, Via Pansini, Napoli-Italia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01829126
- Sponsor's protocol ID
- HEALTH-F5-2012-305495-OT5
- Status last verified
- Nov 2013
- First submitted
- 8 Apr 2013
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Prevention of Severe Heart Disease in Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT01829126
- Acronym / sponsor ID
- HEALTH-F5-2012-305495-OT5
- Conditions
- Systemic Sclerosis, Cardiac Diseases, Heart Block, Cardiac Arrhythmia, Congestive Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 765 participants (estimated)
- Lead sponsor
- Gabriele ValentiniUniversity, hospital or other
- Collaborators
- European Union, University of Giessen, University of Zurich, University of Paris 5 - Rene Descartes, University of Florence, 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
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 11 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 is an orphan, multiorgan disease affecting the connective tissue of the skin and all internal organs. Cardiac involvement, mainly characterised by small intramyocardial coronary artery involvement and myocardial fibrosis, can cause the development of impaired diastolic ventricular filling, cardiac blocks and ventricular arrhythmias, and can ensue in congestive heart failure and sudden death. Until now, no drug has been proven to have a therapeutic effect on SSc myocardial disease on an evidence-based level. Short-term trials and retrospective studies have suggested a favourable and protective effect of calcium channel blockers and angiotensin converting enzyme inhibitors in patients with myocardial involvement. However, no data are presently available on the prevention and treatment of severe heart disease.
This observational trial is part of the collaborative project "DeSScipher", one out of five observational trials to decipher the optimal management of systemic sclerosis. Aim of this observational trial is to assess the efficacy and safety of calcium channel blockers and angiotensin converting enzyme inhibitors in asymptomatic SSc patients with cardiac involvement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CCB | – | –Patients receiving calcium channel blockers (CCB) |
| ACEi | – | –Patients receiving angiotensin converting enzyme inhibitors (ACEi) |
| CCB and ACEi | – | –Patients receiving calcium channel blockers (CCB) and angiotensin converting enzyme inhibitors (ACEi) |
| No treatment | – | –Patients not receiving calcium channel blockers (CCB) and/or angiotensin converting enzyme inhibitors (ACEi) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population are adult and juvenile SSc patients from the EUSTAR cohort (MEDSonline database) and the jSScWG cohort
Key inclusion criteria (3 listed)
- Juvenile and adult systemic sclerosis patients, with diagnosis according to the SSc ACR/EULAR criteria or the PRES/ACR/EULAR juvenile SSc criteria respectively
- Asymptomatic (for cardiac disease) systemic sclerosis patients at risk for severe heart disease with at least one of the following risk factors: male sex and/or DLCO lower than 80% and/or sPAP > 30 mmHg and/or synovitis and/or joint contractures and/or digital ulcers and/or proteinuria.
- Asymptomatic for cardiac disease is defined by patients without dyspnea NYHA >/= II, without palpitations and without bilateral leg edema.
Key exclusion criteria (4 listed)
- Any significant pulmonary parenchymal (FVC < 70% and/or DLCO < 70%), pulmonary vascular (estimated systolic PAP > 40 mmHg), gastrointestinal (malabsorption syndrome or paralytic ileus) or renal (serum creatinine level >1.2 mg/dl, dialysis or previous scleroderma renal crisis) involvement
- Patients with dyspnea class NYHA >/= II
- Patients with palpitations
- Patients with bilateral leg edema.
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
Cumulative incidence of CB, VA, pacemaker implantation, congestive heart failure and sudden death
Time frame: 1 years
Cumulative incidence of cardiac blocks, ventricular arrhythmias, pacemaker implantation, congestive heart failure and sudden death.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 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.
Ulf Müller-Ladner, Prof. study chair
Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
Gabriele Valentini, Prof. principal investigator
Policlinico, Via Pansini, Napoli-Italia
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 Cardiac Diseases, run by Gabriele Valentini 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 4 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 8 Nov 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 Gabriele Valentini, Prof. (39815464487, gabriele.valentini@unina2.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of CB, VA, pacemaker implantation, congestive heart failure and sudden death (time frame: 1 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 8 Nov 2013; AzTrials last refreshed its copy on 7 Nov 2026.