RecruitingPhase 4NCT06782139

Effects of Enavogliflozin on Coronary Microvascular and Cardiac Function in Obesity

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


Sponsor

Korea University Anam Hospital

Enrollment

30 participants

Start Date

Jan 20, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 20 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether enavogliflozin — a newer type 2 diabetes medication (an SGLT2 inhibitor similar to dapagliflozin) — can improve blood flow through the tiny arteries of the heart and improve overall heart function in people who are obese and have diabetes. **You may be eligible if...** - You are between 20 and 79 years old - You are obese or have increased abdominal fat (BMI ≥ 25, or waist over 90 cm for men / 85 cm for women) - You have type 2 diabetes (confirmed by HbA1c, fasting glucose, or current diabetes medication) - You have undergone coronary flow velocity testing **You may NOT be eligible if...** - Your heart's pumping function is reduced (ejection fraction below 50%) - You have a history of heart attack, coronary artery disease, or bypass surgery - You have chest pain with a positive stress test suggesting blocked arteries Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEnavogliflozin

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.

DRUGPlacebo

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.


Locations(1)

Korea University Anam Hospital

Seoul, South Korea

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NCT06782139


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