CarDiab: Diabetic Cardiomyopathy

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT04593173
Collaborator
(none)
77
1
13
5.9

Study Details

Study Description

Brief Summary

Diabetes represents one of the 10 leading causes of death in the world and concerns 5% of the French population (> 3.3 million patients). About 30% of diabetic patients will develop heart failure. The specific and early identification of diabetic cardiomyopathy at a subclinical stage (asymptomatic patients with normal LVEF) will thus make it possible to predict the risk of the onset of heart failure and to strengthen their monitoring and further adapt their treatment.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    77 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Other
    Official Title:
    Diabetic Cardiomyopathy: Diagonostic Value of 2D and 3D Left Ventricular Strains in Echocardiography in Type 2 Diabetic Patients
    Actual Study Start Date :
    Oct 1, 2020
    Actual Primary Completion Date :
    Sep 1, 2021
    Anticipated Study Completion Date :
    Nov 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Analysis of Value of 2D and 3D Left Ventricular Strains in Echocardiography in Type 2 of diabetic Patients [The files analysed retrospectily from April 15, 2015 to April 30, 2019 will be examined]]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adult patient (≥18 years old)

    • Type 2 diabetic and hypertensive subjects, cardiac asymptomatic, without myocardial ischemia documented by Dobutamine stress ultrasound (ESD), having at least 1 additional CV risk factor among: dyslipidemia, active or stopped smoking for less than 3 years, family history (1st degree relationship) of major CV accident before age 60, obliterating arteriopathy of the lower limbs and / or carotid atheroma, or proteinuria.

    • Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

    Exclusion Criteria:
    • Patient who expressed his opposition to participating in the study

    • Valvular heart disease (moderate to severe valve disease), hypertrophic or dilated (MVGi> 95 g / m2 in women and MVGi> 115 g / m2 in men), chronic pulmonary;

    • History of cardiotoxic chemotherapy;

    • Subject under legal protection, under guardianship or under guardianship.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service de Physiologie et d'Explorations Fonctionnelles Strasbourg Starsbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT04593173
    Other Study ID Numbers:
    • 7905
    First Posted:
    Oct 19, 2020
    Last Update Posted:
    Oct 12, 2021
    Last Verified:
    Oct 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Strasbourg, France
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 12, 2021