Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04583800
Recruitment Status : Recruiting
First Posted : October 12, 2020
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Diabetes Mellitus, Type 2 Heart Failure Cognitive Decline

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated 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 : June 22, 2021
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Heart failure (≥ stade B). [ Time Frame: at 48 months ]

Secondary Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
Blood sample

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
People with type 2 diabetes and free of heart failure (≥stade B).
Criteria

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04583800


Contacts
Layout table for location contacts
Contact: Charlotte Cordonnier, MD,PhD 0320445962 precidiab_heart_brain@chru-lille.fr

Locations
Layout table for location information
France
Hopital Roger Salengro, CHU Lille Recruiting
Lille, France, 59037
Contact    0320445962      
Principal Investigator: Charlotte Cordonnier, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
Layout table for investigator information
Principal Investigator: Charlotte Cordonnier, MD,PhD University Hospital, Lille
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT04583800    
Other Study ID Numbers: 2019_66
2020-A01452-37 ( Other Identifier: ID-RCB number,ANSM )
First Posted: October 12, 2020    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: February 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Dementia
Stroke Prevention
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Diabetes Mellitus
Diabetes Mellitus, Type 2
Cognitive Dysfunction
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders