N/A
N=177
Diabetes and Lipid Accumulationand Heart Transplant
Diabetes Mellitus · Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT03546062 ↗Enrolled (actual)
177
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Myocyte Lipid Accumulation as Oil Red-O Positive Biopsie — 54; 21; 0 Endomyocardial Biopsies
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- patients treated by HTx (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Campania Luigi Vanvitelli
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Myocyte Lipid Accumulation as Oil Red-O Positive Biopsie |
54; 21; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- type 2 diabetes mellitus (T2DM);
- heart failure in III/IV NYHA class
- patients with clear indication to receive heart transplantation (HTx).
Exclusion Criteria
- aged 75 years
- non T2DM diagnosis
- controindication to receive HTx.
Data sourced from ClinicalTrials.gov (NCT03546062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.