The goal of this study is to analyze the effects of enavogliflozin on heart function and coronary microvascular function in obese patients compared to a placebo, and to evaluate the improvement in cardiopulmonary exercise capacity in these patients.
None
Left ventricular ejection fraction (LVEF) < 50%
History of coronary artery disease, or patients who have undergone coronary artery intervention or coronary artery bypass grafting.
Patients with suspected obstructive coronary artery disease, including those with chest pain and positive stress test results (e.g., exercise treadmill test, dobutamine stress echocardiography, myocardial perfusion imaging).
Second-degree or higher atrioventricular block, symptomatic bradycardia, sick sinus syndrome, or Wolff-Parkinson-White syndrome.
Parallel
Enavogliflozin
DrugPatients who are enrolled in the study will undergo adenosine stress tests assessing coronary flow velocity reserve and body composition analysis on the day of registration. Within 2 weeks, cardiopulmonary exercise tests will be performed with exhalation gas analysis. After completing the baseline cardiopulmonary exercise capacity evaluation, patients will be assigned to either the enavogliflozin or placebo group and monitored for adverse effects within one month. Patients without significant adverse effects will continue the assigned treatment, and at 12 weeks, they will undergo re-evaluation of coronary flow velocity reserve, body composition analysis, and cardiopulmonary exercise capacity. Adverse events will be monitored from the date of enrollment through the final evaluation.
Placebo
DrugPatients who are enrolled in the study will undergo adenosine stress tests assessing coronary flow velocity reserve and body composition analysis on the day of registration. Within 2 weeks, cardiopulmonary exercise tests will be performed with exhalation gas analysis. After completing the baseline cardiopulmonary exercise capacity evaluation, patients will be assigned to either the enavogliflozin or placebo group and monitored for adverse effects within one month. Patients without significant adverse effects will continue the assigned treatment, and at 12 weeks, they will undergo re-evaluation of coronary flow velocity reserve, body composition analysis, and cardiopulmonary exercise capacity. Adverse events will be monitored from the date of enrollment through the final evaluation.
Coronary microvascular function
The changes in coronary flow velocity reserve at 12 weeks compared to baseline in the active drug/placebo groups
Cardiopulmonary exercise capacity (VO2peak, mL/min/kg)
The changes in cardiopulmonary exercise capacity ((VO2peak, mL/min/kg) at 12 weeks compared to baseline in the active drug/placebo groups
Body weight (kg)
Changes in body weight (kg) at 12 weeks compared to baseline
Systolic and diastolic blood pressure (mmHg)
Changes in Systolic and diastolic blood pressure (mmHg) at 12 weeks compared to baseline
Waist circumference (cm)
Changes in waist circumference (cm) at 12 weeks compared to baseline
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Korea University Anam Hospital
Lead sponsor
Daewoong Pharmaceutical Co. LTD.
Collaborator
