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NCT Number: NCT04583800

Prediction of Heart Failure and Cognitive Decline in Type 2 Diabetes

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cognition Disorders Cognitive Decline Cognitive Dysfunction Dementia Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Heart Failure Mental Disorders Metabolic Diseases Nervous System Diseases Neurocognitive Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Roger Salengro, CHU Lille

Lille, 59037, France

Location status: Recruiting

Location contact

Charlotte Cordonnier, MD,PhD

PRINCIPAL_INVESTIGATOR

CONTACT

0320445962

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Heart failure (≥ stade B).

    Time frame: at 48 months

Secondary outcomes

  1. Cognitive decline (composite endpoint)

    Time frame: 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).

  2. Major cardio-neuro-vascular events

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Charlotte Cordonnier, MD,PhD

CONTACT

[email protected]

0320445962

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study 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

Acronym: PreciDIAB-H&B

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Oct 12, 2020
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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