Systemic SclerosisNCT00617487
Pulmonary Arterial Hypertension in Systemic Sclerosis
An observational study of Systemic Sclerosis and Pulmonary Arterial Hypertension, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 2 sites in Italy.
Trial summary
The purpose of this study is to evaluate the role of stress echocardiography, compared to standard echocardiography in the early identification of pulmonary arterial hypertension in systemic sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Systemic Sclerosis, Pulmonary Arterial Hypertension
- How many people
- 200 participants
- Where
- 2 sitesItaly
- Study dates
- Dec 2007to Jan 2020
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with systemic sclerosis
Who may be able to join
- Patients with systemic sclerosis according to LeRoy criteria
Who cannot join
- Pregnancy
- Significant valvular disease
- Low left ventricular function upon echocardiography (ejection fraction<55%)
- History of atrial fibrillation, myocardial infarction, pulmonary thromboembolisms, neoplasia or severe hepatic disease.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
IRCCS Foundation Policlinico S. Matteo
Pavia, PV, 27100
IRCCS Policlinico S. Matteo
Pavia, PV, 27100
About this study
Official title: Stress Echocardiography in the Early Identification of Pulmonary Arterial Hypertension in Systemic Sclerosis
The purpose of this study is to evaluate the role of stress echocardiography, compared to standard echocardiography in the early identification of pulmonary arterial hypertension in systemic sclerosis. To evaluate the role of BNP in this setting.To analyze data recorded with respect to the parameters commonly used for SSc evaluation (eg thorax HRCT, pulmonary function tests + DLCO, nailfold capillaroscopy, etc); these parameters are available starting for 1999.
- Medical subject headings
- Scleroderma, Systemic, Pulmonary Arterial Hypertension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2008 (estimated)
- Study startDec 2007
- Primary completionMar 2018 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlomaurizio Montecucco, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Stefano Ghio, MD, Study director, IRCCS Foundation Policlinico S. Matteo, CardiologyLorenzo Cavagna, MD, Principal investigator, University and IRCCS Foundation Policlinico S. Matteo, Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617487
- Sponsor's protocol ID
- EchostressSSc
- Status last verified
- Mar 2018
- First submitted
- 6 Feb 2008
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cavagna L, Caporali R, Klersy C, Ghio S, Albertini R, Scelsi L, Moratti R, Bonino C, Montecucco C. Comparison of brain natriuretic peptide (BNP) and NT-proBNP in screening for pulmonary arterial hypertension in patients with systemic sclerosis. J Rheumatol. 2010 Oct;37(10):2064-70. doi: 10.3899/jrheum.090997. Epub 2010 Jul 15.
PubMed 20634241
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Echocardiography in the Early Identification of Pulmonary Arterial Hypertension in Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT00617487
- Acronym / sponsor ID
- EchostressSSc
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 18 Feb 2008 (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.
The purpose of this study is to evaluate the role of stress echocardiography, compared to standard echocardiography in the early identification of pulmonary arterial hypertension in systemic sclerosis. To evaluate the role of BNP in this setting.To analyze data recorded with respect to the parameters commonly used for SSc evaluation (eg thorax HRCT, pulmonary function tests + DLCO, nailfold capillaroscopy, etc); these parameters are available starting for 1999.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with systemic sclerosis
Key inclusion criteria (1 listed)
- Patients with systemic sclerosis according to LeRoy criteria
Key exclusion criteria (4 listed)
- Pregnancy
- Significant valvular disease
- Low left ventricular function upon echocardiography (ejection fraction<55%)
- History of atrial fibrillation, myocardial infarction, pulmonary thromboembolisms, neoplasia or severe hepatic disease.
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- Derived from this study: PubMed 20634241Cavagna L, Caporali R, Klersy C, Ghio S, Albertini R, Scelsi L, Moratti R, Bonino C, Montecucco C. Comparison of brain natriuretic peptide (BNP) and NT-proBNP in screening for pulmonary arterial hypertension in patients with systemic sclerosis. J Rheumatol. 2010 Oct;37(10):2064-70. doi: 10.3899/jrheum.090997. Epub 2010 Jul 15.
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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.
Stefano Ghio, MD study director
IRCCS Foundation Policlinico S. Matteo, Cardiology
Lorenzo Cavagna, MD principal investigator
University and IRCCS Foundation Policlinico S. Matteo, Rheumatology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis and Pulmonary Arterial Hypertension, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 2 sites in Italy.
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 1 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 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00617487, which also lists 1 linked publication.
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 7 Mar 2018.