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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04593173
Other study ID # 7905
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date November 1, 2021

Study information

Verified date October 2020
Source University Hospital, Strasbourg, France
Contact Samy TALHA, MD
Phone 33 3 69 55 13 68
Email samy.talha@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 77
Est. completion date November 1, 2021
Est. primary completion date September 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Service de Physiologie et d'Explorations Fonctionnelles Strasbourg Starsbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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]
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