RecruitingPhase 4NCT07240844

Enavogliflozin for the Management of Patients With Amyloid CardiomyopaThy

Enavogliflozin for the Management of Patients With Amyloid CardiomyopaThy - A Randomized, Double-Blind, Placebo-Controlled, Crossover, Multicenter Trial

Sponsor

Seoul St. Mary's Hospital

Enrollment

68 participants

Start Date

Jan 6, 2026

Study Type

INTERVENTIONAL

Conditions

Amyloid Cardiomyopathy

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.

Eligibility

Min Age: 19 Years

Inclusion Criteria6

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 Criteria17

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

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Interventions

DRUGEnavogliflozin 0.3mg

Participants will receive Enavogliflozin 0.3 mg orally once daily for 12 weeks. The drug is administered in tablet form and is taken during the first or second treatment period of a crossover design.

DRUGPlacebo

Participants will receive placebo orally once daily for 12 weeks. The drug is administered in tablet form and is taken during the first or second treatment period of a crossover design.