Left Ventricular DYsfunction in DiAbetes

Completed

• Conditions: Diabetes Mellitus, Type 2; Heart Diseases; Left Ventricular Dysfunction

• Registration Number: NCT01971125
• Lead Sponsor: Heart Care Foundation

Brief Summary

The purpose of this study is to evaluate the prevalence, during the enrolment, of Left Ventricular Dysfunction diastolic and/or systolic in patients with diabetes mellitus type 2 without known or documented heart disease history and recognize its predictive clinical, biohumoral and with non-invasive techniques parameters.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2009-03
• Study Completion: 2010-11
• Status Verified: 2013-10
• Study First Submitted: 2013-10-23
• Study First Submitted QC: 2013-10-23
• Study First Posted: 2013-10-29
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 970

Inclusion Criteria

• diabetes mellitus type 2
• absence of heart disease previously reported
• age >45 years
• Informed Consent

Exclusion Criteria

• presence of heart disease previously reported
• diabetes type 1
• serious systemic disease, with an expected lifetime lower than 2 years
• no willingness to participate to the screening
• inadequate compliance to study procedure
• participation to other study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of Left Ventricular Dysfunction in patients with type II diabetes	left ventricula dysfunction at enrollment	To evaluate the prevalence of left ventricular dysfunction (LVD), diastolic or systolic in patients with type II diabetes mellitus in the absence of clinical signs/symptoms of cardiac abnormalities To identify the predictors of LVD

Trial Locations

Locations (14)

A.O.- Univ. Ospedali Riuniti; 🇮🇹 Trieste, Friuli - Venezia Giulia, Italy

Casa di Cura Pineta del Carso; 🇮🇹 Duino - Aurisina, Friuli - Venezia Giulia, Italy

Spedali Civili; 🇮🇹 Brescia, Lombardia, Italy

Ospedale San Raffaele; 🇮🇹 Milano, Lombardia, Italy

Azienda Servizi Sanitari N°1 Triestina; 🇮🇹 Trieste, Friuli - Venezia Giulia, Italy

Presidio Ospedaliero; 🇮🇹 Sanremo, Liguria, Italy

Ospedali Riuniti; 🇮🇹 Bergamo, Lombardia, Italy

Ospedale San Paolo; 🇮🇹 Milano, Lombardia, Italy

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Lombardia, Italy

IRCCS Policlinico Multimedica; 🇮🇹 Sesto San Giovanni, Lombardia, Italy

Ospedale Maggiore; 🇮🇹 Chieri, Piemonte, Italy

A.O. Santa Croce e Carle; 🇮🇹 Cuneo, Piemonte, Italy

Ospedale Mauriziano; 🇮🇹 Torino, Piemonte, Italy

Ospedale Civile; 🇮🇹 Mirano, Veneto, Italy