NCT04593173

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

October 12, 2021

Status Verified

October 1, 2020

Enrollment Period

11 months

First QC Date

October 13, 2020

Last Update Submit

October 11, 2021

Conditions

Keywords

DiabetesCardiomyopathyDiabetic CardiomyopathiesType 2 diabetesEchocardiographyLeft ventriclestrain 2D and 3D

Outcome Measures

Primary Outcomes (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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Physiologie et d'Explorations Fonctionnelles

Strasbourg, Starsbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Diabetic CardiomyopathiesDiabetes MellitusCardiomyopathiesDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesDiabetes ComplicationsEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2020

First Posted

October 19, 2020

Study Start

October 1, 2020

Primary Completion

September 1, 2021

Study Completion

November 1, 2021

Last Updated

October 12, 2021

Record last verified: 2020-10

Locations