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Impact of DApagliflozin on Cardiac Function Following Anterior Myocardial Infarction in Non-Diabetic Patients (DACAMI)

Primary Purpose

Anterior MI

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Dapagliflozin 10mg

Glucose Tab

About this trial

This is an interventional prevention trial for Anterior MI focused on measuring Heart Failure, Anterior MI, Dapagliflozin, Sodium Glucose Co-transporter 2 inhibitor, Anterior STEMI, Anterior ST Elevation Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients admitted with ECG Criteria for Anterior ST-elevation myocardial infarction according to the fourth universal definition of myocardial infarction*, ** & show echocardiographic evidence of reduced LV ejection fraction <50% & have undergone successful reperfusion by primary percutaneous coronary angiography (pPCI).
- New ST segment elevation in contagious precordial leads consistent anatomically with the anterior wall of myocardium:
  - Men ≥ 40 years: 2 mV in leads V2-V3 &/or 1 mV in other precordial leads
  - Men <40 years: 2.5 mV in leads V2-V3 &/or 1 mV in other precordial leads
  - Women (regardless of age): 1.5 mV in leads V2-V3 &/or 1 mV in other precordial leads ** Patients with admission ECG showing DeWinter's Syndrome, Wellen Syndrome, New onset left bundle branch block, new onset right bundle branch block will also be included.

Exclusion Criteria:

Patients with Diabetes Miletus (Type 1 (DMT2), Type 1 (DMT1), secondary diabetes (e.g., endocrinopathies)
Patients already diagnosed with heart failure prior to this event
Patients on cardiotoxic chemotherapeutic medications.
Patients with haemoglobinopathies.
Patients with chronic organ damage (i.e., chronic hepatitis with MELD score >10, Stage 4 & 5 renal disease).
Patients already on SGLT2i.
Patients who will require additional anticoagulant therapy (i.e.: patients with transthoracic echocardiographic evidence of left ventricular thrombus).
Patients with contraindications for use of dapagliflozin including patients with severely impaired renal function (eGFR <30ml/min/1.73m2) &/OR previous history of genitourinary infections (i.e.: urosepsis, pyelonephritis & fournier's gangrene) &/OR at high risk of such infections.

Sites / Locations

Cardiology Department, Faculty of Medicine, Ain Shams University
National Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention Group

Control Group

Arm Description

Participants will receive Dapagliflozin 10mg once daily.

Participants will receive a glucose tab once daily.

Outcomes

Primary Outcome Measures

A change in NT-proBNP levels from baseline to 12 weeks post-anterior STEMI

Difference between both groups in the change of NT-proBNP levels from baseline to 12 weeks post-anterior STEMI

A change in left ventricular ejection fraction, end-diastolic volume or left ventricular mass index assessed by transthoracic echocardiography at baseline, 4 weeks & 12 weeks post-anterior STEMI

Difference between both groups in the change of the above mentioned echocardiographic parameters assessed at baseline, 4 weeks & 12 weeks post-anterior STEMI

Secondary Outcome Measures

Full Information

NCT ID

NCT05424315

First Posted

June 15, 2022

Last Updated

June 25, 2022

Sponsor

Omar Younis

Collaborators

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT05424315

Brief Title

Impact of DApagliflozin on Cardiac Function Following Anterior Myocardial Infarction in Non-Diabetic Patients

Acronym

DACAMI

Official Title

Impact of DApagliflozin on Cardiac Function Following Anterior Myocardial Infarction in Non-Diabetic Patients - DACAMI (a Randomized Controlled Clinical Trial)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

October 1, 2021 (Actual)

Primary Completion Date

April 30, 2022 (Actual)

Study Completion Date

April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Omar Younis

Collaborators

Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Sodium glucose co-transporter 2 inhibitors (SGLT2i) proved their favorable outcomes in heart failure. However, it is still unknown if their role extent into preventing heart failure, especially after acute myocardial infarction. This study aimed at identifying if there is such role for SGLT2i.

Detailed Description

A notable breakthrough in the management of heart failure is the use of a class of anti-diabetic medications known as, gliflozins. Gliflozins act by inhibiting the sodium glucose co-transporter 2 (SGLT-2). This is a transmembrane protein found at the luminal border of tubular cells of the proximal convoluted tubules of the kidney. It accounts for around 90% of glucose re-absorption. Inhibiting the SGLT-2 results in better glycemic control in patient with diabetes mellitus type 2 (DMT2). In heart failure, sodium glucose co-transporter 2 inhibitors (SGLT2i - i.e., gliflozins) were found to have a favorable cardiovascular outcome independent of their anti-glycemic effect. In patients with acute myocardial infarction, the heart function as a pump is affected & heart failure develops. In particular, patients with anterior ST-elevation myocardial infarction (STEMI) are at a higher risk of remodeling & heart failure. This is due to the cutoff in blood supply in the left anterior descending (LAD) coronary artery which supplies a great area of left ventricle. A question that rises: is there a role for SGLT2i, & in particular dapagliflozin, in acute myocardial infarction in improving post-infarction cardiac function & preventing heart failure? especially in patients who experience Anterior ST-Elevation Myocardial Infarction (STEMI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anterior MI

Keywords

Heart Failure, Anterior MI, Dapagliflozin, Sodium Glucose Co-transporter 2 inhibitor, Anterior STEMI, Anterior ST Elevation Myocardial Infarction

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Active Comparator

Arm Description

Participants will receive Dapagliflozin 10mg once daily.

Arm Title

Control Group

Arm Type

Placebo Comparator

Arm Description

Participants will receive a glucose tab once daily.

Intervention Type

Drug

Intervention Name(s)

Dapagliflozin 10mg

Intervention Description

10mg Tab once daily

Intervention Type

Drug

Intervention Name(s)

Glucose Tab

Intervention Description

Placebo Oral Tablet

Primary Outcome Measure Information:

Title

A change in NT-proBNP levels from baseline to 12 weeks post-anterior STEMI

Description

Difference between both groups in the change of NT-proBNP levels from baseline to 12 weeks post-anterior STEMI

Time Frame

12 weeks

Title

A change in left ventricular ejection fraction, end-diastolic volume or left ventricular mass index assessed by transthoracic echocardiography at baseline, 4 weeks & 12 weeks post-anterior STEMI

Description

Difference between both groups in the change of the above mentioned echocardiographic parameters assessed at baseline, 4 weeks & 12 weeks post-anterior STEMI

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients admitted with ECG Criteria for Anterior ST-elevation myocardial infarction according to the fourth universal definition of myocardial infarction*, ** & show echocardiographic evidence of reduced LV ejection fraction <50% & have undergone successful reperfusion by primary percutaneous coronary angiography (pPCI). New ST segment elevation in contagious precordial leads consistent anatomically with the anterior wall of myocardium: Men ≥ 40 years: 2 mV in leads V2-V3 &/or 1 mV in other precordial leads Men <40 years: 2.5 mV in leads V2-V3 &/or 1 mV in other precordial leads Women (regardless of age): 1.5 mV in leads V2-V3 &/or 1 mV in other precordial leads ** Patients with admission ECG showing DeWinter's Syndrome, Wellen Syndrome, New onset left bundle branch block, new onset right bundle branch block will also be included. Exclusion Criteria: Patients with Diabetes Miletus (Type 1 (DMT2), Type 1 (DMT1), secondary diabetes (e.g., endocrinopathies) Patients already diagnosed with heart failure prior to this event Patients on cardiotoxic chemotherapeutic medications. Patients with haemoglobinopathies. Patients with chronic organ damage (i.e., chronic hepatitis with MELD score >10, Stage 4 & 5 renal disease). Patients already on SGLT2i. Patients who will require additional anticoagulant therapy (i.e.: patients with transthoracic echocardiographic evidence of left ventricular thrombus). Patients with contraindications for use of dapagliflozin including patients with severely impaired renal function (eGFR <30ml/min/1.73m2) &/OR previous history of genitourinary infections (i.e.: urosepsis, pyelonephritis & fournier's gangrene) &/OR at high risk of such infections.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Khairy Abdul-Dayem, M.D.

Organizational Affiliation

Cardiology Department, Faculty of Medicine, Ain Shams University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cardiology Department, Faculty of Medicine, Ain Shams University

City

Cairo

Country

Egypt

Facility Name

National Heart Institute

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

IPD will be available through a data repository link provided to the publishing journal. Shared Data will include baseline characteristics of the intervention and control group. Moreover, NT-proBNP and Echocardiographic outcomes will be available.

IPD Sharing Time Frame

Access to the data will be feasible once the results are published.

IPD Sharing Access Criteria

Access to the data will be feasible once the results are published after a formal request to the investigators. Approval of the the investigators is a must.

Citations:

PubMed Identifier

26378978

Citation

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Impact of DApagliflozin on Cardiac Function Following Anterior Myocardial Infarction in Non-Diabetic Patients

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