Evaluation of NT-proBNP in Chronic Inflammatory Bowel Dis... | NCT03107390

Studies
Evaluation of NT-proBNP in Chronic Inflammatory Bowel Disease

NCT03107390

Sponsor

Centre Hospitalier Universitaire, Amiens

Status

Terminated

Last Update Posted

Jul 15, 2020Actual

Enrollment

159Actual

Phase

Not Applicable

Conditions

Inflammatory Bowel Diseases
NT-pro-BNP

Interventions

Evaluate the blood level of NTproBNP

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

investigator choice

Expanded Access Info

Start Date

Oct 28, 2013Actual

Primary Completion Date

Aug 7, 2017Actual

Completion Date

Aug 7, 2017Actual

First Submitted Date

Apr 5, 2017

First Submission Date that Met QC Criteria

Apr 10, 2017

First Posted Date

Apr 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2020

Last Update Posted Date

Jul 15, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

159Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with CD or RCH	Other		Other: Evaluate the blood level of NTproBNP
The control population	Other		Other: Evaluate the blood level of NTproBNP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Evaluate the blood level of NTproBNP	Other	Evaluate the blood level of NTproBNP in patients with MICI compared to a healthy control population.	Patients with CD or RCH

Measure	Description	Time Frame
Blood level of NTproBNP.		1 month

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
CHU Amiens Picardie		Amiens	Picardie	80054	France

Condition Browse Module

MeSH Terms

ID	Term
D015212	Inflammatory Bowel Diseases

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided