Enavogliflozin for the Management of Patients With Amyloid CardiomyopaThy (NCT07240844) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Enavogliflozin for the Management of Patients With Amyloid CardiomyopaThy
South Korea68 participantsStarted 2025-11-24
Plain-language summary
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.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
✕. 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)