Effect of Dapagliflozin on LV Remodeling Post AMI | NCT04783870

Studies
Effect of Dapagliflozin on LV Remodeling Post AMI

NCT04783870

Sponsor

Instituto Mexicano del Seguro Social

Status

Unknown status

Last Update Posted

Mar 5, 2021Actual

Enrollment

60Estimated

Phase

Phase 4

Conditions

Myocardial Infarction

Interventions

Dapagliflozin
Placebo

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 3, 2021Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Mar 2, 2021

First Submission Date that Met QC Criteria

Mar 2, 2021

First Posted Date

Mar 5, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2021

Last Update Posted Date

Mar 5, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eduardo Almeida Gutiérrez, MD, Instituto Mexicano del Seguro SocialPrincipal Investigator

Lead Sponsor

Instituto Mexicano del Seguro SocialOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dapagliflozin	Experimental	Dapagliflozin 10 mg PO QD	Drug: Dapagliflozin
Control	Placebo Comparator	Placebo PO QD	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dapagliflozin	Drug	Dapagliflozin 10 mg PO QD	Dapagliflozin
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Left ventricular remodeling	Changes in end-diastolic and end-systolic left ventricular volumes	6 months

Secondary Outcomes

Measure	Description	Time Frame
Natriuretic peptides	Change in natriuretic peptide	6 months
Quality of life assessed with KCCQ	Change in quality of life	6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eduardo Almeida-Gutierrez, MD	Contact	+52 5556276900	22007	eduardo.almeida@imss.gob.mx

Overall Officials

Name	Affiliation	Role
Juan B Ivey-Miranda, MD	Instituto Mexicano del Seguro Social	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Cardiología, Centro Médico Nacional Siglo XXI	Recruiting	Mexico City		06720	Mexico

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

IPD will be shared only to researches with extensive research. These will be analyzed on case-by-case basis.

Types

Study Protocol
Clinical Study Report (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.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009203	Myocardial Infarction

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C529054	dapagliflozin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided