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

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

This study tests if the drug enavogliflozin can improve heart and blood vessel function in obese patients and help them exercise better.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 20 Years to 79 Years
• Sex: All
• Sponsor: Korea University Anam Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Seoul)
• Trial ID: NCT06782139 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are obese individuals aged 20 to 79 years with type 2 diabetes.

Not a fit: Patients with left ventricular ejection fraction below 50% or a history of coronary artery disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved heart function and exercise capacity in obese patients, potentially reducing the risk of heart failure.

How similar studies have performed: Previous studies have shown that SGLT2 inhibitors can significantly benefit heart failure and cardiovascular health, indicating a promising approach in this area.

Eligibility criteria

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 this trial is running

Seoul

• 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

Conditions Obesity and Type 2 Diabetes; Sodium-Glucose Cotransporter 2 inhibitors; Obesity; Diabetes; Coronary microvascular function; Epicardial adipose tissue