Effects of enavogliflozin on heart and blood vessel function in obese patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates how enavogliflozin, a sodium-glucose cotransporter 2 inhibitor, impacts heart function and coronary microvascular function in obese patients compared to a placebo. It aims to evaluate improvements in cardiopulmonary exercise capacity among participants. The study focuses on the relationship between obesity, coronary microvascular dysfunction, and cardiovascular health, particularly in the context of heart failure with preserved ejection fraction. Participants will undergo various assessments, including echocardiography and blood tests, to determine eligibility and monitor outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Korea University Anam Hospital
  Seoul, South Korea Recruiting

Study contacts

• Principal investigator: Seong-Mi Park, M.D., Ph.D. — Korea University Anam Hospital
• Study coordinator: So Ree Kim, MD, PhD
• Email: soree8826kim@gmail.com
• Phone: 82029205445

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.