Diabetic Cardiomyopathy (CarDiab)

October 11, 2021 updated by: University Hospital, Strasbourg, France

Diabetic Cardiomyopathy: Diagonostic Value of 2D and 3D Left Ventricular Strains in Echocardiography in Type 2 Diabetic Patients

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

77

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Starsbourg
      • Strasbourg, Starsbourg, France, 67091
        • Recruiting
        • Service de Physiologie et d'Explorations Fonctionnelles
        • Sub-Investigator:
          • Patrick OHLMANN, MD, PhD
        • Sub-Investigator:
          • Marc-André Goltzene, MD
        • Contact:
        • Principal Investigator:
          • Samy TALHA, MD
        • Sub-Investigator:
          • Emmanuel ANDRES, MD, PhD
        • Sub-Investigator:
          • Bernard GENY, MD, PhD
        • Sub-Investigator:
          • Soraya EL GHANNUDI-ABDO, MD
        • Sub-Investigator:
          • Dominique PARIS-BOCKEL, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Type 2 diabetic and hypertensive patients, treated in the Internal Medicine and Diabetology Services of Strasbourg University Hospitals, between 04/15/2015 to 04/30/2019.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Analysis of Value of 2D and 3D Left Ventricular Strains in Echocardiography in Type 2 of diabetic Patients
Time Frame: The files analysed retrospectily from April 15, 2015 to April 30, 2019 will be examined]
The files analysed retrospectily from April 15, 2015 to April 30, 2019 will be examined]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

September 1, 2021

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

October 13, 2020

First Submitted That Met QC Criteria

October 13, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

October 12, 2021

Last Update Submitted That Met QC Criteria

October 11, 2021

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7905 (OTHER: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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