Inflammatory Bowel DiseasesNT-pro-MICINCT03107390
Evaluation of NT-proBNP in Chronic Inflammatory Bowel Disease
A study testing Evaluate the blood level of NTproBNP in people with Inflammatory Bowel Diseases and NT-pro-BNP, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
NT-proBNP is a major diagnostic and prognostic marker in cardiology, but it is also a new marker for biological inflammation, especially in rheumatology. Its evaluation in chronic inflammatory bowel disease was carried out in a preliminary study, the OPERA study where in a population of 12 patients showed an increase… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, NT-pro-BNP
- What is being tested?
- Evaluate the blood level of NTproBNP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteFrance
- Study dates
- 28 Oct 2013to 7 Aug 2017
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects (age 18 years)
- MICI Group: Patients monitored for probable HC or MC
- Control group: Patients referred for consultation in gastroenterology with a clinical and endoscopic picture eading to the diagnosis of TF I
- Person who agreed to participate in the study
- Patient covered by social insurance
Who cannot join
- Causes of increased concentrations of natriuretic peptides: acute heart failure, acute or chronic pulmonary disease with right ventricular repercussion, valvulopathies, primary or secondary HVG, atrial fibrillation cardiac arrhythmia, chronic systolic dysfunction, hyperthyroidism, Addison's disease, hyperaldosteronism Primary, diabetes, cirrhosis with ascites, cancers, chronic renal insufficiency.
- Inflammatory and autoimmune diseases (excluding MC and RCH), chronic inflammatory syndrome
- Ongoing treatment that may affect the concentration of natriuretic peptides: ACE inhibitor, angiotensin II receptor antagonists, diuretics
- Patient deprived of liberty or protected major (under guardianship or curatorship)
Trial locations and contacts
1 site in 1 country.
About this study
NT-proBNP is a major diagnostic and prognostic marker in cardiology, but it is also a new marker for biological inflammation, especially in rheumatology.
Its evaluation in chronic inflammatory bowel disease was carried out in a preliminary study, the OPERA study where in a population of 12 patients showed an increase in NT-proBNP correlated with the biological and endoscopic activity of the disease. This larger study is therefore a pilot study that could see NTproBNP as a new biomarker of inflammation in MICI.
- Conditions
- Inflammatory Bowel Diseases, NT-pro-BNP
- Being tested
- Evaluate the blood level of NTproBNP
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluate the blood level of NTproBNPOther
Evaluate the blood level of NTproBNP in patients with MICI compared to a healthy control population.
| Study group | Role | What they receive |
|---|---|---|
| Patients with CD or RCH | Other | Not described Receives: Other: Evaluate the blood level of NTproBNP |
| The control population | Other | Not described Receives: Other: Evaluate the blood level of NTproBNP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood level of NTproBNP.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start28 Oct 2013
- Primary completion7 Aug 2017
- Study completion7 Aug 2017
Why it stopped: investigator choice
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107390
- Sponsor's protocol ID
- PI2013_843_0015
- Acronym
- NT-pro-MICI
- Status last verified
- Jul 2020
- First submitted
- 5 Apr 2017
- Last updated
- 15 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of NT-proBNP in Chronic Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT03107390
- Acronym / sponsor ID
- NT-pro-MICI / PI2013_843_0015
- Conditions
- Inflammatory Bowel Diseases, NT-pro-BNP
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: investigator choice
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 28 Oct 2013 (actual)
- Primary completion
- 7 Aug 2017 (actual)
- Study completion
- 7 Aug 2017 (actual)
- First posted
- 11 Apr 2017 (actual)
- 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.
NT-proBNP is a major diagnostic and prognostic marker in cardiology, but it is also a new marker for biological inflammation, especially in rheumatology.
Its evaluation in chronic inflammatory bowel disease was carried out in a preliminary study, the OPERA study where in a population of 12 patients showed an increase in NT-proBNP correlated with the biological and endoscopic activity of the disease. This larger study is therefore a pilot study that could see NTproBNP as a new biomarker of inflammation in MICI.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with CD or RCH | Other | Other: Evaluate the blood level of NTproBNP |
| The control population | Other | Other: Evaluate the blood level of NTproBNP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult subjects (age 18 years)
- MICI Group: Patients monitored for probable HC or MC
- Control group: Patients referred for consultation in gastroenterology with a clinical and endoscopic picture eading to the diagnosis of TF I
- Person who agreed to participate in the study
- Patient covered by social insurance
Key exclusion criteria (4 listed)
- Causes of increased concentrations of natriuretic peptides: acute heart failure, acute or chronic pulmonary disease with right ventricular repercussion, valvulopathies, primary or secondary HVG, atrial fibrillation cardiac arrhythmia, chronic systolic dysfunction, hyperthyroidism, Addison's disease, hyperaldosteronism Primary, diabetes, cirrhosis with ascites, cancers, chronic renal insufficiency.
- Inflammatory and autoimmune diseases (excluding MC and RCH), chronic inflammatory syndrome
- Ongoing treatment that may affect the concentration of natriuretic peptides: ACE inhibitor, angiotensin II receptor antagonists, diuretics
- Patient deprived of liberty or protected major (under guardianship or curatorship)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluate the blood level of NTproBNPEvaluate the blood level of NTproBNP in patients with MICI compared to a healthy control population. | Other | Patients with CD or RCH, The control population |
Primary outcome
Blood level of NTproBNP.
Time frame: 1 month
Results and safety
The study was stopped early (reason given: investigator choice). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluate the blood level of NTproBNP in people with Inflammatory Bowel Diseases and NT-pro-BNP, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 5 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: stopped early, as of the sponsor's last update on 15 Jul 2020. 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 France. 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?
The study was stopped early (reason given: investigator choice). 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.
What does the primary outcome measure?
Blood level of NTproBNP. (time frame: 1 month). 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 15 Jul 2020.