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EFFECTS OF ANTIDIABETIC MEDICATION-SGLT2 INHIBITOR IN POST HEART ATTACK PATIENTS WITH HEART FAILURE

EFFECTS OF SGLT2 INHIBITORS ON LEFT VENTRICULAR DIMENSIONS AND FUNCTION IN MYOCARDIAL INFARCTION PATIENTS WITH LEFT VENTRICULAR DYSFUNCTION

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/12/029493
Enrollment
134
Registered
2020-12-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I219- Acute myocardial infarction, unspecified

Interventions

Intervention1: To evaluate the changes in Left ventricular dimensions and function in extensive myocardial infarction (MI) patients on SGLT2 inhibitors. : a) To compare the improvement in left ventric

Sponsors

Department of Cardiology Kasturba Medical College and Hospital Manipal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Extensive MI 2. LVEF 3. Diagnosed with T2DM, defined as: • Prior documentation of type 2 diabetes AND/OR • Treatment with anti-hyperglycemic medications and/or diet AND/OR • ADA criteria: fasting >126 mg/dl (7.0 mmol/L) or HbA1C >=6.5% or 2-h plasma glucose>=200 mg/dl (11.1 mmol/L) during an oral glucose tolerance test, or a random plasma glucose >= 200 mg/dL (11.1 mmol/L) in patients with classic symptoms of hyperglycemia or hyperglycemic crisis. 4. Creatinine clearance of 30 ml or more per minute. 5. Patients on optimal antidiabetic therapy of oral hypoglycemic agents including SGLT2 inhibitors and/or insulin. 6. On optimal therapy post MI including dual antiplatelets, statins,beta blockers/ARBâ??s/ACE inhibitors, aldosterone antagonists and/or diuretics, if tolerated.

Exclusion criteria

Exclusion criteria: 1. Severe infection 2. Serious liver or renal functional failure (estimated glomerular filtration rate [eGFR] 3. Alcohol dependency or use of illicit drugs 4. Pregnant or breastfeeding, possibly pregnant, or planning to become pregnant in the study period (female patients only) 5. Dehydration (abnormal hematocrit [Ht] and blood urea nitrogen, symptoms of dehydration);urinary tract or genital infection 6. History of hypersensitivity to the study drugs 7. Severe ketosis, diabetic coma or precoma 8. Ongoing or past history of pancreatitis

Design outcomes

Primary

MeasureTime frame
The primary outcome measured in this study will be change in LV mass index from baseline to mean of 3-6 months at follow up. Secondary outcomes include changes in Left Ventricular Ejection fraction Area Length Ejection Fraction (ALEF) Left ventricular End Diastolic Volume and index Left ventricular End Systolic Volume and index E/E: ratio between early mitral inflow velocity and mitral annular early diastolic velocity Left atrial volume and Index LV contractility dp/dt Timepoint: 0 AND 6 MONTHS

Secondary

MeasureTime frame
Secondary outcomes include changes in Left Ventricular Ejection fraction Area Length Ejection Fraction (ALEF) Left ventricular End Diastolic Volume and index Left ventricular End Systolic Volume and index E/E: ratio between early mitral inflow velocity and mitral annular early diastolic velocity Left atrial volume and Index LV contractility dp/dtTimepoint: 0 AND 6 MONTHS

Countries

India

Contacts

Public ContactJIJIN SATHEESH

Katurba Medical College

padma.kumar@manipal.edu9900921428

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026