Prediction of Heart Failure and Cognitive Decline in Type 2 Diabetes

Heart Failure Clinical Trial

— PreciDIAB-H&B  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04583800
• Other study ID #: 2019_66
• Secondary ID: 2020-A01452-37
• Status: Recruiting
• Start date: June 22, 2021
• Est. completion date: June 2025

Study information

• Verified date: February 2022
• Source: University Hospital, Lille
• Contact: Charlotte Cordonnier, MD,PhD
• Phone: 0320445962
• Email: precidiab_heart_brain[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Heart Failure

Locations

Country	Name	City	State
France	Hopital Roger Salengro, CHU Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart failure (= stade B).		at 48 months
Secondary	Cognitive decline (composite endpoint)	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).	at 48 months
Secondary	Major cardio-neuro-vascular events	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.	at 48 months