The Effect of Early Initiation of SGLT2 Inhibitors in Reducing Heart Failure Events After MI

Phase 3

• Conditions: Acute Coronary SyndromesHeart failure; Acute Coronary Syndromes; Myocardial in fraction; Heart failure; Sodiumâ€glucose cotransporter 2 inhibitors (SGLT2i)

• Registration Number: TCTR20200306004
• Lead Sponsor: Faculty of Medicine, Chiang Mai University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-06
• Study Completion: 2022-05-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 476

Inclusion Criteria

1.Male or female patients ≥ 35 years of age
2.Diagnosis of ACS based on the 4th universal definition between 24 hours and 10 days before treatment allocation
3.LVEF ≤ 40% after index MI or
4.LVEF > 40% with symptomatic heart failure requiring iv diuretic or elevate natriuretic peptides NT-proBNP ≥ 600 pg/ml, if atrial fibrillation or flutter ≥ 900 pg/ml with Killip class II to IV
5.Hemodynamic stable defined as SBP ≥ 100 mmHg at initiation of treatment, no symptomatic hypotension
6.No increase in intravenous diuretics
7.No intravenous inotrope or intravenous vasodilators
8.Received revascularization to IRA with PCI

Exclusion Criteria

1.Cardiogenic shock within last 24 hours prior to the screening
2.Planned CABG or cardiac surgery within next 3 months
3.Symptomatic hypotension at screening
4.Stroke or TIA 1 month prior to the screening
5.History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
6.Impaired renal function, defined as GFR < 30 ml/min (MDRD formula) at screening
7.Diagnosis of Myocardial Infarction with Nonobstructive Coronary Arteries (MINOCA)
8.Life expectancy < 1 year
9. Prior diagnosis of heart failure

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outpatient HF or hospitalization for HF 12 months Number of OPD and IPD visit,Outpatient HF or hospitalization for HF 12 months number of OPD and IPD visit,Outpatient HF or hospitalization for HF 12 months number of OPD and IPD visit

Secondary Outcome Measures

Name	Time	Method
Orthostatic hypotension day 1 to day 365 Blood pressure,Worsening of renal function week 2 eGFR level,Proportional change in plasma NT-proBNP week 2 and week 6 NT-proBNP level,3-point MACE 1 year Number of MACE event,LV remodeling 6 week Percentage of LVEF from Echocardiogram,LV remodeling 6 week Percentage of LVEF from Cardiac MRI,Mitochondrial function and metobolomic function 1 year Mitochondrial and metobolomic activity