Effect of Dapagliflozin on LV Remodeling Post AMI
Effect of Dapagliflozin on Left Ventricular Remodeling in Patients With Acute Myocardial Infarction
1 other identifier
interventional
60
1 country
1
Brief Summary
The overall hypothesis of the study is that Dapagliflozin will reduce left ventricular remodeling in patients who have had a myocardial infarction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2021
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2021
CompletedStudy Start
First participant enrolled
March 3, 2021
CompletedFirst Posted
Study publicly available on registry
March 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedMarch 5, 2021
March 1, 2021
2.8 years
March 2, 2021
March 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Left ventricular remodeling
Changes in end-diastolic and end-systolic left ventricular volumes
6 months
Secondary Outcomes (2)
Natriuretic peptides
6 months
Quality of life assessed with KCCQ
6 months
Study Arms (2)
Dapagliflozin
EXPERIMENTALDapagliflozin 10 mg PO QD
Control
PLACEBO COMPARATORPlacebo PO QD
Interventions
Eligibility Criteria
You may qualify if:
- Acute myocardial infarction treated within the 24 hours of beginning of symptoms
- Signed informed consent
- SBP \> 90 mmHg
- Age \>= 18 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Cardiología, Centro Médico Nacional Siglo XXI
Mexico City, 06720, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juan B Ivey-Miranda, MD
Instituto Mexicano del Seguro Social
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Participants will receive either Dapagliflozin or Placebo. They will not know which arm they have been allocated to.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 2, 2021
First Posted
March 5, 2021
Study Start
March 3, 2021
Primary Completion
December 31, 2023
Study Completion
December 31, 2024
Last Updated
March 5, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- After the study termination
- Access Criteria
- IPD will be shared only to researches with extensive research. These will be analyzed on case-by-case basis.
IPD will be shared only to researches with extensive research. These will be analyzed on case-by-case basis.