Enavogliflozin for the Management of Patients With Amyloid CardiomyopaThy
ConditionAmyloid Cardiomyopathy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorSeoul St. Mary's Hospital
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Enavogliflozin 0.3mg
- Placebo
Treatment groups
68 Participants
are divided into 2 treatment groupsSponsors and collaborators
Seoul St. Mary's Hospital
Lead sponsor
Samsung Medical Center
Collaborator
Source ClinicalTrials.gov