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Evaluation of NT-proBNP in Chronic Inflammatory Bowel Disease (NT-pro-MICI)

Primary Purpose

Inflammatory Bowel Diseases, NT-pro-BNP

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Evaluate the blood level of NTproBNP
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inflammatory Bowel Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • CHU Amiens Picardie

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patients with CD or RCH

The control population

Arm Description

Outcomes

Primary Outcome Measures

Blood level of NTproBNP.

Secondary Outcome Measures

Full Information

First Posted
April 5, 2017
Last Updated
July 13, 2020
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT03107390
Brief Title
Evaluation of NT-proBNP in Chronic Inflammatory Bowel Disease
Acronym
NT-pro-MICI
Official Title
Evaluation of NT-proBNP in Chronic Inflammatory Bowel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
investigator choice
Study Start Date
October 28, 2013 (Actual)
Primary Completion Date
August 7, 2017 (Actual)
Study Completion Date
August 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, NT-pro-BNP

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with CD or RCH
Arm Type
Other
Arm Title
The control population
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Evaluate the blood level of NTproBNP
Intervention Description
Evaluate the blood level of NTproBNP in patients with MICI compared to a healthy control population.
Primary Outcome Measure Information:
Title
Blood level of NTproBNP.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France

12. IPD Sharing Statement

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Evaluation of NT-proBNP in Chronic Inflammatory Bowel Disease

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