Diabetic Cardiomyopathy

Diabetic Cardiomyopathies Clinical Trial

— CarDiab  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04593173
• Other study ID #: 7905
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Diabetic Cardiomyopathies

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]