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
• Status: Terminated
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases
• NT-pro-BNP

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