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Effect of Dapagliflozin on LV Remodeling Post AMI

Primary Purpose

Myocardial Infarction

Status
Recruiting
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Dapagliflozin
Placebo
Sponsored by
Instituto Mexicano del Seguro Social
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction

Eligibility Criteria

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

Inclusion Criteria:

  • Acute myocardial infarction treated within the 24 hours of beginning of symptoms
  • Signed informed consent
  • SBP > 90 mmHg
  • Age >= 18 years

Exclusion Criteria:

  • Glomerular Filtration Rate < 30 ml/min/1.73 m2.
  • Pregnant or lactating woman
  • Cancer or life-threatening condition
  • Use of continuous parental inotropic agents
  • Psychiatric disease incompatible with being in study.
  • Any contraindication to MRI procedures.
  • Any other medical or physical condition considered to be inappropriate by a study physician
  • Scheduled for a PCI or CABG within the next 6 months
  • Hemodynamic unstability
  • Currently on any SGLT2i
  • One or more episodes of severe hypoglicemia
  • Acute urinary or genital infection

Sites / Locations

  • Hospital de Cardiología, Centro Médico Nacional Siglo XXIRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dapagliflozin

Control

Arm Description

Dapagliflozin 10 mg PO QD

Placebo PO QD

Outcomes

Primary Outcome Measures

Left ventricular remodeling
Changes in end-diastolic and end-systolic left ventricular volumes

Secondary Outcome Measures

Natriuretic peptides
Change in natriuretic peptide
Quality of life assessed with KCCQ
Change in quality of life

Full Information

First Posted
March 2, 2021
Last Updated
March 2, 2021
Sponsor
Instituto Mexicano del Seguro Social
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1. Study Identification

Unique Protocol Identification Number
NCT04783870
Brief Title
Effect of Dapagliflozin on LV Remodeling Post AMI
Official Title
Effect of Dapagliflozin on Left Ventricular Remodeling in Patients With Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Mexicano del Seguro Social

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The overall hypothesis of the study is that Dapagliflozin will reduce left ventricular remodeling in patients who have had a myocardial infarction.
Detailed Description
In patients with heart failure, with or without diabetes, SGLT2i have shown to decrease remodeling. However, this has not been tested in patients following an acute myocardial infarction. Acute myocardial infarction is serious condition with increasing incidence across the world. Following treatment, a reasonable amount of patients develop remodeling of the left ventricle, which is associated with worse prognosis. This occurs despite patients are treated with GDMT. Dapagliflozin is an SGLT2i with biological plausibility to decrease left ventricular remodeling following acute myocardial infarction. In the present study, researchers will test the hypothesis that Dapagliflozin will reduce left ventricular remodeling in patients who have had a myocardial infarction (less than 7 days). This will be a randomized, single-blind, placebo controlled trial. The primary endpoint will be the change in end-diastolic and end-systolic left ventricular volumes from baseline to the end of the intervention (6 months). We will include patients with acute myocardial infarction who have been treated with primary PCI.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Participants will receive either Dapagliflozin or Placebo. They will not know which arm they have been allocated to.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dapagliflozin
Arm Type
Experimental
Arm Description
Dapagliflozin 10 mg PO QD
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo PO QD
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Intervention Description
Dapagliflozin 10 mg PO QD
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Left ventricular remodeling
Description
Changes in end-diastolic and end-systolic left ventricular volumes
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Natriuretic peptides
Description
Change in natriuretic peptide
Time Frame
6 months
Title
Quality of life assessed with KCCQ
Description
Change in quality of life
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute myocardial infarction treated within the 24 hours of beginning of symptoms Signed informed consent SBP > 90 mmHg Age >= 18 years Exclusion Criteria: Glomerular Filtration Rate < 30 ml/min/1.73 m2. Pregnant or lactating woman Cancer or life-threatening condition Use of continuous parental inotropic agents Psychiatric disease incompatible with being in study. Any contraindication to MRI procedures. Any other medical or physical condition considered to be inappropriate by a study physician Scheduled for a PCI or CABG within the next 6 months Hemodynamic unstability Currently on any SGLT2i One or more episodes of severe hypoglicemia Acute urinary or genital infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eduardo Almeida-Gutierrez, MD
Phone
+52 5556276900
Ext
22007
Email
eduardo.almeida@imss.gob.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan B Ivey-Miranda, MD
Organizational Affiliation
Instituto Mexicano del Seguro Social
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Cardiología, Centro Médico Nacional Siglo XXI
City
Ciudad de México
ZIP/Postal Code
06720
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan B Ivey-Miranda, MD
Phone
+52 5543683768
Email
betuel.ivey@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be shared only to researches with extensive research. These will be analyzed on case-by-case basis.
IPD Sharing Time Frame
After the study termination
IPD Sharing Access Criteria
IPD will be shared only to researches with extensive research. These will be analyzed on case-by-case basis.

Learn more about this trial

Effect of Dapagliflozin on LV Remodeling Post AMI

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