PreciDIAB-H&B: Prediction of Heart Failure and Cognitive Decline in Type 2 Diabetes

Sponsor

University Hospital, Lille (Other)

Overall Status

Recruiting

CT.gov ID

NCT04583800

Collaborator

(none)

600

Enrollment

Location

47.3

Anticipated Duration (Months)

12.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Type 2 diabetes is a risk factor of heart failure and cognitive decline. Heart failure at its early stage is often silent. At present, primary prevention for heart failure is not available. Our aim is to identify diabetic patients at risk of heart failure in order to develop personalized preventive strategies.

Type 2 diabetes is vascular and metabolic risk factor for cognitive decline though a direct lesional effect but also through an interaction with underlying neurodegenerative lesions. Our aim is to identify diabetic patients at risk of cognitive decline in order to develop personalized preventive strategies

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2 Heart Failure Cognitive Decline

Study Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prediction of Heart Failure and Cognitive Decline in Type 2 Diabetes : Longitudinal Cohort Study of Immuno-inflammation, Cardiac Energetics and Cognition.PreciDIAB-HEART&BRAIN

Actual Study Start Date :

Jun 22, 2021

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Jun 1, 2025

Outcome Measures

Primary Outcome Measures

Heart failure (≥ stade B). [at 48 months]

Secondary Outcome Measures

Cognitive decline (composite endpoint) [at 48 months]
a decrease in cognitive performance quantified at 1.5 standard deviation on at least 1 neuropsychological test within a cognitive domain (attention and speed of information processing, memory, executive functions) compared to the neuropsychological assessment performed at inclusion. Appearance of dementia defined as a cognitive disorder highlighted in the neuropsychological evaluation carried out at the end of the study leading to a loss of functional autonomy in activities of daily living defined by the loss of at least 1 point on the activities of daily living ADL scale (DSM V).
Major cardio-neuro-vascular events [at 48 months]
cardioneurovascular event (composite endpoint) defined by the occurrence of death from any cause, myocardial infarction, stroke (ischemic or hemorrhagic), acute limb ischemia or a doubling of creatinine.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adults
Persons able to understand and object to the information provided.
Type 2 diabetic patient free of heart failure ≥stade B
Patient affiliated with a social security scheme.
Patient agreeing to sign the informed consent form

Exclusion Criteria:

Patient with dementia
Patient with at least one of the criteria for heart failure ≥stade B

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopital Roger Salengro, CHU Lille	Lille		France	59037

Sponsors and Collaborators

University Hospital, Lille

Investigators

Principal Investigator: Charlotte Cordonnier, MD,PhD, University Hospital, Lille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Lille

ClinicalTrials.gov Identifier:

NCT04583800

Other Study ID Numbers:

2019_66
2020-A01452-37

First Posted:

Oct 12, 2020

Last Update Posted:

Mar 2, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Lille

Dementia

Stroke Prevention

Additional relevant MeSH terms:

Heart Failure

Diabetes Mellitus

Diabetes Mellitus, Type 2

Cognitive Dysfunction

Study Results

No Results Posted as of Mar 2, 2022