Effect of Dapagliflozin Administration on the Apoptosis Levels of Patients with Acute Myocardial Infarction (DAPOPTOSIS-MI)

February 24, 2025 updated by: Yoga Yudhistira

The Effect of Dapagliflozin on the Apoptosis Levels of Patients with Acute Myocardial Infarction - DAPOPTOSIS-MI (a Randomized Controlled Trial)

The currently known Sodium-Glucose Transporter 2 (SGLT-2) inhibitors are recognized not only for their effects on improving intravascular glucose levels but also for their cardioprotective effects, including improvements in endothelial dysfunction, inhibition of platelet activation, reduction in autophagy processes, oxidative stress, and inflammation, as well as inhibition of the Na+/H+ exchanger pathway, which potentially reduces cell damage and death resulting from ischemia and reperfusion processes. Research on the benefits of SGLT-2 inhibitors in pre-clinical studies with myocardial infarction has shown a significant reduction in myocardial apoptosis, indicated by reduced levels of caspase-3 and the apoptosis index. Additionally, there was an increase in ketone bodies and myocardial ATP, reduced levels of inflammatory cytokines, free radicals, and infarct area, as well as improvements in left ventricular ejection fraction. However, large-scale studies in humans have thus far been limited to investigating the effects of SGLT-2 inhibitors on mortality, rehospitalization rates due to heart failure, cardiometabolic factors, and improvements in remodeling parameters in myocardial infarction patients, with the use of empagliflozin or dapagliflozin. Based on literature reviews, there have been no studies to date that directly demonstrate the effects of dapagliflozin on apoptosis (caspase-3 levels) in myocardial infarction patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is a randomized controlled trial, single-center study in Acute Myocardial Infarction (AMI) patients held in Moewardi General Hospital, Central Java, Indonesia. The investigator divided 40 patients with AMI into two groups, the first is the Dapagliflozin group, which will get 10mg of Dapagliflozin once a day every morning and the second group will have a placebo once a day every morning also for 14 days. Each patient will be checked for Caspase-3 level from blood serum as primary outcome and Global Work (GW) echocardiographic parameters such as GWI, GCW, GWW, and GWE as secondary outcome at admission and 14 days after intervention. The study was approved by the hospital ethics committee. The clinical parameters above will then be analyzed. To determine the mean difference between unpaired groups (treatment and control), an independent T-test is used if the distribution is normal (if not, the Mann-Whitney test is used). Normality testing is performed using the Shapiro-Wilk test, considering the sample size is less than 50.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Central of Java
      • Surakarta, Central of Java, Indonesia, 57126
        • Dr. Moewardi General Hospital, Jebres, Surakarta, Central of Java, 57126

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with Acute Myocardial Infarction (STEMI or NSTEMI) according to the Fourth Universal Definition of Myocardial Infarction from the European Society of Cardiology, American College of Cardiology, American Heart Association, and World Heart Federation.
  2. Aged 18-75 years
  3. Willing to participate in the study and sign informed consent.

Exclusion Criteria:

  1. Patients with cardiogenic shock (SBP ≤ 80 mmHg, cold extremities, urine output <0.5 ml/kg/hr) <24 hours before randomization
  2. Patients with ketoacidosis (arterial pH <7.30, serum bicarbonate <18 mEq/l, positive ketonuria)
  3. Patients with impaired renal function with an estimated glomerular filtration rate (eGFR) <20 ml/min or requiring dialysis
  4. Patients with a history of chronic heart failure before the onset of Acute Myocardial Infarction
  5. Patients scheduled for coronary artery bypass surgery
  6. Patients with type 1 diabetes mellitus
  7. Patients with severe valvular disease
  8. Patients with sepsis
  9. Patients with symptomatic acute urinary tract infection
  10. Pregnant patients
  11. Patients with severe aortic stenosis or LVOT obstruction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dapagliflozin
The intervention group will have dapagliflozin 10mg once a day every morning besides standard treatment of Acute Coronary Syndrome for 14 days before further evaluation
Drug: Forxiga® 10 mg Film-Coated Tablet, manufactured by AstraZeneca Pharmaceuticals LP, USA for AstraZeneca Pharmaceuticals Co. Ltd., China imported by PT AstraZeneca Indonesia, Indonesia
The first group is the Dapagliflozin group, which will get Dapagliflozin 10mg once a day every morning for 14 days. And the second group will have placebo for 14 days.
Experimental: Control
The first group is the Dapagliflozin group, which will get Dapagliflozin 10mg once a day every morning for 14 days. And the second group will have placebo for 14 days.
Drug: Forxiga® 10 mg Film-Coated Tablet, manufactured by AstraZeneca Pharmaceuticals LP, USA for AstraZeneca Pharmaceuticals Co. Ltd., China imported by PT AstraZeneca Indonesia, Indonesia
The first group is the Dapagliflozin group, which will get Dapagliflozin 10mg once a day every morning for 14 days. And the second group will have placebo for 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Biomolecular Parameters
Time Frame: 14 days
Change in Caspase-3 (ng/L) level in blood serum patients
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Echocardiographic Parameters
Time Frame: 14 days
Change in Global Work Index (GWI) (mmHg%), Global Constructive Work (GCW) (mmHg%), Global Wasted Work (GWW) (mmHg%), Global Work Efficiency (GWE) (%) parameter from patients
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yoga Yudhistira

Investigators

  • Principal Investigator: Yoga Yudhistira MD, Dr. Moewardi General Hospital, Jebres, Surakarta, Central of Java, 57126
  • Study Director: Ahmad Yasa MD, Dr. Moewardi General Hospital, Jebres, Surakarta, Central of Java, 57126

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2024

Primary Completion (Actual)

November 30, 2024

Study Completion (Actual)

December 7, 2024

Study Registration Dates

First Submitted

September 21, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S5121020014865

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This study was conducted as part of the final project for the cardiovascular residency program, there was no sponsorship during this study therefore the IPD cannot be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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