Prediction of Heart Failure and Cognitive Decline in Type 2 Diabetes

Recruiting

• Conditions: Heart Failure; Cognitive Decline; Diabetes Mellitus, Type 2

• Registration Number: NCT04583800
• Lead Sponsor: University Hospital, Lille

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-28
• Study First Submitted QC: 2020-10-05
• Study First Posted: 2020-10-12
• Study Start: 2021-06-22
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-02
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Heart failure (≥ stade B).	at 48 months

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hopital Roger Salengro, CHU Lille; 🇫🇷 Lille, France