NCT05305911

Brief Summary

The purpose of the research is to determine whether a class of medication called SGLT2 inhibitor will improve the heart's function and reduce its enlargement after a heart attack. Participation in this study will involve taking this class of medication (or a placebo) once daily for six months, one cardiac magnetic resonance imaging (MRI) test during your initial hospitalization, follow-up phone calls at 1 and 3 months, and one cardiac MRI and clinic visit at six months. This is a single center study.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for phase_2

Timeline
31mo left

Started Aug 2022

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Aug 2022Dec 2028

First Submitted

Initial submission to the registry

March 14, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

August 3, 2022

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

6.3 years

First QC Date

March 14, 2022

Last Update Submit

October 3, 2024

Conditions

Heart AttackEnlarged Heart

Keywords

DapagliflozinSodium Glucose Co-Transporter 2

Outcome Measures

Primary Outcomes (2)

  • Change in LVESVI

    Change in LVESVI at 6 months as measured by MRI.

    6 Months

  • Change in LVEDVI

    Change in LVEDVI at 6 months as measured by MRI.

    6 Months

Secondary Outcomes (3)

  • Change in LV mass

    6 months

  • Change in LVEF

    6 months

  • MACE rates - including hospitalization for CHF, repeat revascularization, MI and death and ICD implantation

    1 year

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

Treatment group will receive SGLT2 inhibitor in addition to standard heart attack medications for the duration of hospitalization and 6-month duration of the study.

Drug: SGLT-2 inhibitors

Placebo Group

PLACEBO COMPARATOR

Placebo Group will receive placebo in addition to standard heart attack medications for the duration of hospitalization and 6-month duration of the study.

Drug: Placebo

Interventions

SGLT-2 inhibitorsDRUG

SGLT2 inhibitor once daily for six months

Treatment Group
PlaceboDRUG

Placebo once daily for six months

Placebo Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with their first STEMI (\>18 years) who underwent successful primary PCI and able to give informed consent
  • At least mild LV dysfunction (LVEF \< 50%) on echocardiogram, cMRI or Left Ventriculargram following PCI
  • Infarct size that is \> 10% of LV mass
  • The presence of MVO that is \> 10% of infarct size

You may not qualify if:

  • Contraindication to cardiac MRI
  • Life expectancy \< 1 year
  • Previous CABG or Valve Surgery
  • Previous STEMI
  • Pregnant or planning to become pregnant or lactating women
  • Cardiogenic shock (not resolved)
  • Atrial fibrillation or recurrent sustained ventricular arrhythmias (excluding PVCs)
  • GFR\<30 ml/min/1.73m2 or end-stage renal disease on dialysis
  • Type 1 diabetes mellitus or history of diabetic ketoacidosis
  • Type I or II diabetes with insulin use
  • Prior intolerance of SGLT2 inhibitors
  • Current use of SGLT2 inhibitors (randomized patients only)
  • Contraindications to gadolinium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

RECRUITING

MeSH Terms

Conditions

Myocardial InfarctionCardiomegaly

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisHypertrophyPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesHypoglycemic AgentsPhysiological Effects of Drugs

Study Officials

  • Jay Traverse, MD

    Minneapolis Heart Institute Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Schwager, RN

CONTACT

612-863-3833sarah.schwager@allina.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Treatment will be blinded to the participant and investigator. Assignment of treatment arm will be managed by Abbott Northwestern Heart Hospital pharmacy.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2022

First Posted

March 31, 2022

Study Start

August 3, 2022

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

October 8, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)