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NCT03107390 Clinical Trial

Evaluation of NT-proBNP in Chronic Inflammatory Bowel Disease

Inflammatory Bowel Diseases Clinical Trial

— NT-pro-MICI  

Official title:
Evaluation of NT-proBNP in Chronic Inflammatory Bowel Disease

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03107390
Other study ID # PI2013_843_0015
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 28, 2013
Est. completion date August 7, 2017

Study information
Verified date July 2020
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.

Recruitment information / eligibility
Status Terminated
Enrollment 159
Est. completion date August 7, 2017
Est. primary completion date August 7, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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)

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Evaluate the blood level of NTproBNP
Evaluate the blood level of NTproBNP in patients with MICI compared to a healthy control population.

Locations
Country Name City State
France CHU Amiens Picardie Amiens Picardie

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood level of NTproBNP. 1 month
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