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NCT03546062: DCM-AHEAD

Diabetes and Lipid Accumulationand Heart Transplant

Completed Results posted Last updated 20 April 2023
What this trial tests

trial testing patients treated by HTx in Diabetes Mellitus in 177 participants. Completed in 1 May 2018.

Timeline
1 January 2010
Primary endpoint
1 January 2018
1 May 2018

Quick facts

Lead sponsorUniversity of Campania Luigi Vanvitelli
StatusCompleted
Study typeOBSERVATIONAL
Enrollment177
Start date1 January 2010
Primary completion1 January 2018
Estimated completion1 May 2018
Sites2 locations across Italy

Drugs / interventions tested

Conditions studied

Sponsor

University of Campania Luigi Vanvitelli

Who can join

Adults 18 to 75, any sex, with Diabetes Mellitus or Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Myocyte Lipid Accumulation as Oil Red-O Positive Biopsie Primary · 12 months.

Authors will evaluate myocyte lipid accumulation as Oil Red-O positive biopsie after heart transplant at follow up.

GroupValue95% CI
Diabetic Metformin Group54
Diabetic Group Without Metformin Therapy21
Non-diabetic Group0

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 month. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Diabetic Metformin Group
Serious: 0/35 (0%)
Deaths: 0/35
Diabetic Without Metformin Group
Serious: 0/41 (0%)
Deaths: 0/41
Non Diabetic Patients
Serious: 0/82 (0%)
Deaths: 0/82

Serious adverse events (1 terms)

ReactionSystemDiabetic Metformin GroupDiabetic Without Metformin…Non Diabetic Patients
rejectionCardiac disorders

Most-reported serious reactions: rejection.

Data from ClinicalTrials.gov NCT03546062 adverse events section.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Epigenetic regulation in cardiovascular disease: mechanisms and advances in clinical trials.
    Shi Y, Zhang H, Huang S, Yin L, et al · · 2022 · cited 233× · PMID 35752619 · DOI 10.1038/s41392-022-01055-2
  2. Glycated ACE2 receptor in diabetes: open door for SARS-COV-2 entry in cardiomyocyte.
    D'Onofrio N, Scisciola L, Sardu C, Trotta MC, et al · · 2021 · cited 76× · PMID 33962629 · DOI 10.1186/s12933-021-01286-7
  3. Lipid Accumulation in Hearts Transplanted From Nondiabetic Donors to Diabetic Recipients.
    Marfella R, Amarelli C, Cacciatore F, Balestrieri ML, et al · · 2020 · cited 51× · PMID 32192650 · DOI 10.1016/j.jacc.2020.01.018
  4. Clinical epigenetics settings for cancer and cardiovascular diseases: real-life applications of network medicine at the bedside.
    Sarno F, Benincasa G, List M, Barabasi AL, et al · · 2021 · cited 49× · PMID 33785068 · DOI 10.1186/s13148-021-01047-z
  5. Epigenetic Therapies for Heart Failure: Current Insights and Future Potential.
    Napoli C, Bontempo P, Palmieri V, Coscioni E, et al · · 2021 · cited 26× · PMID 34079271 · DOI 10.2147/vhrm.s287082
  6. Current Insights into miRNA and lncRNA Dysregulation in Diabetes: Signal Transduction, Clinical Trials and Biomarker Discovery.
    Pandey A, Ajgaonkar S, Jadhav N, Saha P, et al · · 2022 · cited 14× · PMID 36297381 · DOI 10.3390/ph15101269
  7. Glycated ACE2 reduces anti-remodeling effects of renin-angiotensin system inhibition in human diabetic hearts.
    Marfella R, D'Onofrio N, Mansueto G, Grimaldi V, et al · · 2022 · cited 14× · PMID 35932065 · DOI 10.1186/s12933-022-01573-x

Verify or expand the search:

Other recruiting trials for Diabetes Mellitus

Currently open trials in the same condition.

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