Effects of Enavogliflozin on Coronary Microvascular and Cardiac Function in Obesity

RECRUITING

NCT06782139

PHASE4

Sponsor: Korea University Anam Hospital

Summary

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.

Official title: Effects of ENavogliflozin on Coronary microVascular and Cardiac Function in Patients With obesitY (ENVY)

Key Details

Gender

All

Age Range

20 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-01-20

Completion Date

2025-12-31

Last Updated

2025-09-02

Healthy Volunteers

No

Conditions

Obesity and Type 2 Diabetes

Interventions

DRUG

Enavogliflozin

Patients 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.

DRUG

Placebo

Patients 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.

Inclusion Criteria: The following criteria must be met for inclusion in the study: 1. Obesity or Abdominal Obesity: Body Mass Index (BMI) ≥ 25 kg/m², or Waist circumference: Male ≥ 90 cm, Female ≥ 85 cm. 2. Diabetes: Hemoglobin A1c ≥ 6.5%, or Fasting blood glucose ≥ 126 mg/dL after 8 hours of fasting, or Currently on antidiabetic medication. Blood test results must be within 3 months prior to enrollment. Other inclusion criteria: Age between 20 and 79 years. Patients who have undergone coronary flow velocity reserve testing. For baseline echocardiography, left ventricular diastolic dysfunction will be evaluated structurally (LV dimension, LV mass index, LA size) and hemodynamically (Doppler data, left ventricular ejection fraction, strain data). Exclusion Criteria: 1. Left ventricular ejection fraction (LVEF) \< 50% 2. History of coronary artery disease, or patients who have undergone coronary artery intervention or coronary artery bypass grafting. 3. 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). 4. Second-degree or higher atrioventricular block, symptomatic bradycardia, sick sinus syndrome, or Wolff-Parkinson-White syndrome. 5. Chronic kidney disease (GFR \< 30 mL/min/1.73 m²) or end-stage renal disease on hemodialysis or peritoneal dialysis. 6. Asthma, chronic obstructive pulmonary disease, or primary pulmonary hypertension. 7. Moderate or severe valvular heart disease or congenital heart disease, or patients with a history of open-heart surgery. 8. Active cancer within the last 5 years, or patients currently receiving chemotherapy. 9. Vasculitis associated with autoimmune diseases, such as systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). 10. Patients who cannot undergo exercise testing, such as treadmill or bicycle ergometer testing. 11. Use of any other SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin) within the past 6 months, or a known allergy to these drugs. 12. Pregnant or breastfeeding women. 13. Women planning pregnancy during the study period (or within 24 weeks from the start of the study, including the 12-week observation period). 14. Acute urinary tract infection at the time of enrollment.

Locations (1)

Korea University Anam Hospital

Seoul, South Korea

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