Systemic SclerosisNCT00453752
Non-Invasive Diagnostic and Functional Evaluation of Cardiac Involvement in Patients With Systemic Sclerosis
An observational study of Systemic Sclerosis, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The aim of this study was to assess serum N-terminal proBNP (NT-proBNP) in systemic sclerosis patients and to establish whether it reflects the severity of RV overload. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Sclerosis
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- Apr 2006to Apr 2010
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of systemic sclerosis
Who cannot join
- Cardiovascular disorders other than pulmonary hypertension
- Significant pulmonary function abnormalities
- Impaired renal function
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Michał Ciurzyński
Warsaw, Lindleya 4, 02-005
Michał Ciurzyński, M.D, Ph.D, +48 22 502 11 44, mciurzyn@amwaw.edu.pl
About this study
The aim of this study was to assess serum N-terminal proBNP (NT-proBNP) in systemic sclerosis patients and to establish whether it reflects the severity of RV overload.
Read the detailed description
Elevated serum brain natriuretic peptide (BNP) levels released from myocytes of ventricles upon stretch have been found in patients with isolated right ventricular (RV) pressure overload. However, limited data suggest that serum BNP may be elevated in patients with systemic sclerosis (SSc), especially with RV dysfunction. The aim of this study was to assess serum N-terminal proBNP (NT-proBNP) in SSc patients and to establish whether it reflects the severity of RV overload.
- Conditions
- Systemic Sclerosis
- Keywords
- systemic sclerosis, pulmonary hypertension, echocardiography, N-Terminal proBNP
- Medical subject headings
- Scleroderma, Systemic, Hypertension, Pulmonary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2007 (estimated)
- Study startApr 2006
- Study completionApr 2010 (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.
- More trials run by Medical University of WarsawThe 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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Investigators
- Michał Ciurzyński, M.D., Ph.D, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453752
- Sponsor's protocol ID
- KB/66/2006
- Status last verified
- Mar 2006
- First submitted
- 28 Mar 2007
- Last updated
- 29 Mar 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Diagnostic and Functional Evaluation of Cardiac Involvement in Patients With Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT00453752
- Acronym / sponsor ID
- KB/66/2006
- Conditions
- Systemic Sclerosis
- Keywords
- systemic sclerosis, pulmonary hypertension, echocardiography, N-Terminal proBNP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Apr 2006
- Study completion
- Apr 2010 (estimated)
- First posted
- 29 Mar 2007 (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 aim of this study was to assess serum N-terminal proBNP (NT-proBNP) in systemic sclerosis patients and to establish whether it reflects the severity of RV overload.
Detailed description
Elevated serum brain natriuretic peptide (BNP) levels released from myocytes of ventricles upon stretch have been found in patients with isolated right ventricular (RV) pressure overload. However, limited data suggest that serum BNP may be elevated in patients with systemic sclerosis (SSc), especially with RV dysfunction. The aim of this study was to assess serum N-terminal proBNP (NT-proBNP) in SSc patients and to establish whether it reflects the severity of RV overload.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of systemic sclerosis
Key exclusion criteria (3 listed)
- Cardiovascular disorders other than pulmonary hypertension
- Significant pulmonary function abnormalities
- Impaired renal function
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 29 Mar 2007.
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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.
Michał Ciurzyński, M.D., Ph.D principal investigator
Medical University of Warsaw
1 site 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, run by Medical University of Warsaw at 1 site in Poland.
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 3 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 29 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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 Ciurzyński Michał, M.D, Ph.D (+48 22 502 11 44, mciurzyn@amwaw.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 29 Mar 2007.