CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 177 enrolled
Drug / intervention
patients treated by HTxother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03546062
NCT03546062N/ACompleted

Lipid Accumulation in Heart Transplant From Non-diabetic Donors to Diabetic Recipients

University of Campania Luigi Vanvitelli·observational·Posted Jun 6, 2018·Updated Apr 20, 2023

In Brief

An observational study evaluating patients treated by HTx for Diabetes Mellitus and Heart Failure. Completed, enrolled 177 participants across 2 sites.

Detailed Summary

Idiopathic dilated cardiomyopathy (IDC) is defined by the presence of left ventricular systolic dysfunction in the absence of an abnormal loading condition or significant coronary artery disease. IDC is the main cause of end-stage heart failure (HF) and is responsible for half of all heart transplants (HTx). Endocrine disorders, including diabetes, are known to be associated with IDC. Diabetes mellitus (DM), which is present in 75% of patients with idiopathic IDC, is an independent risk factor for the development of heart failure and death in IDC. Therefore, DM can exacerbate the need for HTx, in addition, diabetic patients are less suitable for HTx and DM remains an independent risk factor for death even after HTx. Recent studies have revealed the presence of diabetic cardiomyopathy, a condition of myocardial dysfunction without coronary artery disease. This term was introduced for the first time by Rubler et al. in 1972 which highlighted patients with diabetes and congestive heart failure with normal coronary arteries. The pathophysiological mechanisms through which diabetes affects the development and progression of diabetic heart disease are not known. Therefore, the purpose of our study will be to evaluate, in the explanted diabetic heart, the presence of possible cellular alterations attributable to the diabetic disease. Furthermore, the progression of these lesions in the transplanted heart in diabetic patients will be evaluated.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 6, 2018
Enrollment StartJan 1, 2010
Primary CompletionJan 1, 2018
Study CompletionMay 1, 2018
TodayJul 2, 2026
Enrollment to primary: 8 yearsPosted 8.1 years ago

Interventions

patients treated by HTxother

From removed and frozen hearts, authors will conduct a tissue and molecular analysis of possible mechanisms T2DM linked.