The goal of this trial is to to determine whether use of a novel SGLT2 inhibitor, Enavogliflozin 0.3 mg once daily is superior to placebo, when added to standard-of-care, in reducing the composite of major cardiovascular events and Heart Failure events (hospitalization for Heart Failure or urgent Heart Failure visit) among patients who underwent transcatheter aortic valve replacement for severe aortic stenosis and with heart failure with preserved ejection fraction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,040
0.3 mg 1 tablet once daily
Standard-of-Care medical therapy plus Enavogliflozin matching placebo
Bucheon Sejong Hospital
Bucheon-si, South Korea
RECRUITINGGyeongsang National University Changwon Hospital
Changwon, South Korea
RECRUITINGDaegu Catholic University Medical Center
Daegu, South Korea
RECRUITINGKeimyung University Dongsan Medical Center
Daegu, South Korea
Time from randomization to first occurrence of a composite of major adverse cardiovascular events* or hospitalization for heart failure
Time from randomization to the first occurrence of a composite of major adverse cardiovascular events\* or hospitalization for heart failure at 12 months after randomization. \*Major adverse cardiovascular events included death from any causes, nonfatal myocardial infarction, or nonfatal stroke. A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed.
Time frame: 12 months
Event rate of death from any cause
Time frame: 12 months
Event rate of nonfatal myocardial infarction
Time frame: 12 months
Event rate of nonfatal stroke
Time frame: 12 months
Event rate of hospitalization for heart failure
Time frame: 12 months
Event rate of Composite renal endpoint
Composite renal endpoint, defined as time to first occurrence of (1) chronic dialysis; (2) renal transplantation; (3) sustained reduction of ≥40% in estimated glomerular filtration rate (GFR); or (4) sustained estimated GFR \<15 mL/min/1.73 m2 for patients with baseline estimated GFR ≥30 mL/min/1.73 m2.
Time frame: 12 months
Event rate of Rehospitalization for any reason
Time frame: 12 months
Changes in measures of cardiac volume and function assessed by serial echocardiography
left ventricular ejection fraction(LVEF), LV end-diastolic volume index (LVEDVI), LV end-systolic volume index (LVESVI), left atrial volume index (LAVI), and the ratio of early transmitral Doppler velocity/early diastolic annular velocity (E/e')
Time frame: 12 months
Changes in New York Heart Association (NYHA) functional class and the Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score
New York Heart Association (NYHA) Functional Classification on a scale from I to IV, with higher scores indicating severe symptoms and physical limitations associated with heart failure. the Kansas City Cardiomyopathy Questionnaire (KCCQ)on a scale from 0 to 100, with higher scores indicating fewer symptoms and physical limitations associated with heart failure.
Time frame: 12 months
Serial change in NT-proBNP
N-terminal (NT)-pro hormone BNP (NT-proBNP)
Time frame: 12 months
Event rate of the safety events
The safety events are defined as; * Serious adverse events * Adverse events leading to treatment discontinuation * Adverse events of special interest(AESI) * Hypoglycemia, genitourinary infections, hepatic injury, decreased renal function, ketoacidosis, events leading to lower limb amputation * AESIs leading to treatment discontinuation
Time frame: 12 months
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Kyungpook National University Hospital
Daegu, South Korea
RECRUITINGYeungnam University Medical Center
Daegu, South Korea
NOT_YET_RECRUITINGChungnam National University Hospital
Daejeon, South Korea
RECRUITINGThe Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon, South Korea
RECRUITINGGangneung Asan Hospital
Gangneung, South Korea
RECRUITINGChonnam National University Hospital
Gwangju, South Korea
RECRUITING...and 21 more locations