Enavogliflozin for the Management of Patients With Amyloid CardiomyopaThy

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Amyloid Cardiomyopathy

In brief

This study aims to evaluate the safety and effectiveness of Enavogliflozin 0.3 mg, an SGLT2 inhibitor, in patients with amyloid cardiomyopathy. Participants will take both the study drug and a placebo in two separate periods, with a wash-out period in between. The goal is to determine whether Enavogliflozin is safe and effective for treating amyloid cardiomyopathy.

Key facts

Study ID

NCT07240844

Run by

Seoul St. Mary's Hospital

People needed

68

Starts

2026-01-06

Expected to finish

2027-05-31

Last updated by the study team

2026-06-18

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 19 years or older
• Diagnosed with amyloid cardiomyopathy confirmed by cardiac biopsy or non-invasive imaging
• Presence of heart failure symptoms corresponding to NYHA functional class II-III
• Patients on stable oral diuretic use, without dose changes exceeding 50% of the previous dose, for at least 2 weeks prior to study enrollment
• Ambulatory (able to walk)
• Able to provide written informed consent for study participation

You may not qualify if…

• Pregnant or breastfeeding women
• Active infection
• Major cardiovascular events (e.g., myocardial infarction, stroke) within the past 6 months
• Scheduled for coronary revascularization, CRT-D implantation, atrial flutter/fibrillation ablation, or valve surgery
• History of heart transplantation
• Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m² (calculated by CKD-EPI formula)
• No history of cancer within the past 5 years at screening (except borderline cancers without recurrence for 2-3 years; multiple myeloma with cardiac involvement is classified as cardiac amyloidosis and is exempt)
• Heart failure primarily caused by severe left sided valvular disease or ischemic heart disease (except if valvular disease is corrected)
• Type 1 diabetes mellitus or insulin-dependent diabetes
• History of ketoacidosis, complicated urinary or genital infections, or kidney stones
• Systolic blood pressure < 80 mmHg or symptomatic hypotension
• Major surgery within 90 days prior to enrollment
• Known hypersensitivity or allergic reaction to the study drug or its components
• Moderate to severe liver impairment
• Chronic alcohol or substance abuse
• Residing in long-term care facilities (e.g., nursing homes)
• Unable to understand or comply with study drug, procedures, or follow-up, or who are deemed by the investigator to be unlikely to complete the study

Where it is running

• Samsung Medical Center — Seoul, South Korea (enrolling)
• Seoul St. Mary's Hospital, The Catholic University of Korea — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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