NCT03546062|CompletedResults
Diabetes and Lipid Accumulationand Heart Transplant
DCM-AHEAD
Lipid Accumulation in Heart Transplant From Non-diabetic Donors to Diabetic Recipients
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Sponsor study identifier
observational
177
1 country
2
Study Start
January 1, 2010
Actual (reported)Primary Completion
January 1, 2018
Actual (reported)Study Completion
May 1, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2010
Actual (reported)January 1, 2018
Actual (reported)May 1, 2018
Actual (reported)May 22, 2018
Actual (reported)June 6, 2018
Actual (reported)April 20, 2023
Actual (reported)Myocyte Lipid Accumulation as Oil Red-O Positive Biopsie
Authors will evaluate myocyte lipid accumulation as Oil Red-O positive biopsie after heart transplant at follow up.
12 months.
Authors will include a population of T2DM patients with advanced heart failure and treated by heart transplant. 41 patients recluted from January 2015
Authors will include a population of T2DM patients with advanced heart failure and treated by heart transplant in metformin therapy. 35 patients recluted from January 2015
Authors will include a population of non-diabetic patients with advanced heart failure treated by heart transplant. 82 patients recluted from January 2015
From removed and frozen hearts, authors will conduct a tissue and molecular analysis of possible mechanisms T2DM linked.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Two main groups according to whether patients did or did not have pre-transplantation diabetes. Patients with DM for at least 6 months before HTX, with optimal glycemic control (HbA1c \<7.0), BMI \<30kg/m2, without severe secondary end-organ disease will be included. Patients with endomyocardial biopsy specimens consistent with ISHLT Grade 2R considered positive for rejection, increased T4/T8 ratio, positive IgM and/or IgG Cytomegalovirus antibodies, and with post-HTX diabetes will be excluded.
Celestino Sardu
Naples, 80138, Italy
Raffaele Marfella
Naples, 80138, Italy
Marfella R, D'Onofrio N, Mansueto G, Grimaldi V, Trotta MC, Sardu C, Sasso FC, Scisciola L, Amarelli C, Esposito S, D'Amico M, Golino P, De Feo M, Signoriello G, Paolisso P, Gallinoro E, Vanderheyden M, Maiello C, Balestrieri ML, Barbato E, Napoli C, Paolisso G. Glycated ACE2 reduces anti-remodeling effects of renin-angiotensin system inhibition in human diabetic hearts. Cardiovasc Diabetol. 2022 Aug 5;21(1):146. doi: 10.1186/s12933-022-01573-x.
Marfella R, D'Onofrio N, Trotta MC, Sardu C, Scisciola L, Amarelli C, Balestrieri ML, Grimaldi V, Mansueto G, Esposito S, D'Amico M, Golino P, Signoriello G, De Feo M, Maiello C, Napoli C, Paolisso G. Sodium/glucose cotransporter 2 (SGLT2) inhibitors improve cardiac function by reducing JunD expression in human diabetic hearts. Metabolism. 2022 Feb;127:154936. doi: 10.1016/j.metabol.2021.154936. Epub 2021 Nov 18.
The patients received in the past heart transplant. In the removed and frizzed hearts authors will extract portions of septal wall. From this tissue authors will analyze inflammatory markers and microRNAs involved in the progression of cardiac disease.
Our real life study is not multi-center study and thus we need to extend our observations to a larger cohort of randomized patients. Second, immunosuppressive therapy by per se could affect molecular mechanisms of DMCM.
Raffaele Marfella, MD
University of Campania Luigi Vanvitelli
177 participants (actual enrollment reported by the registry).
First Submitted
May 22, 2018
First Posted
June 6, 2018
Study Start
January 1, 2010
Actual (reported)Contact the study team to confirm eligibility.
Marfella R, Amarelli C, Cacciatore F, Balestrieri ML, Mansueto G, D'Onofrio N, Esposito S, Mattucci I, Salerno G, De Feo M, D'Amico M, Golino P, Maiello C, Paolisso G, Napoli C. Lipid Accumulation in Hearts Transplanted From Nondiabetic Donors to Diabetic Recipients. J Am Coll Cardiol. 2020 Mar 24;75(11):1249-1262. doi: 10.1016/j.jacc.2020.01.018.
Primary Completion
January 1, 2018
Actual (reported)Study Completion
May 1, 2018
Actual (reported)Last Updated
April 20, 2023
Results First Posted
April 20, 2023
Record last verified: 2023-04
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Source: ClinicalTrials.gov.
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