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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Enavogliflozin 0.3mg
DrugParticipants 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.
Placebo
DrugParticipants 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.
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: EnavogliflozinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in KCCQ-CSS from baseline to Week 12
Change in the Clinical Summary Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-CSS) from baseline to 12 weeks after treatment initiation. The KCCQ-CSS is a patient-reported outcome measure that assesses symptom frequency and physical limitation in patients with heart failure. Scores range from 0 to 100, with higher scores indicating better symptom status and physical function (i.e., better health status). A higher change from baseline reflects an improvement in clinical status.
Time frame
Baseline and Week 12Secondary outcomes
1
Change in 6-Minute Walk Distance
Change in distance walked in 6 minutes from baseline to Week 12. Higher distance indicates better exercise capacity.
Time frame
Baseline and Week 122
Change in log-transformed NT-proBNP levels
Change in log-transformed NT-proBNP levels after 12 weeks of treatment compared to baseline
Time frame
Baseline and Week 123
Change in Body Weight
Change in body weight in kilograms from baseline to Week 12
Time frame
Baseline and Week 124
Change in Body Fat Percentage
Change in body fat percentage from baseline to Week 12
Time frame
Baseline and Week 12Other outcomes
1
Change in maximal oxygen consumption (VO₂ max)
Change in VO₂ max measured by cardiopulmonary exercise testing (CPET) from baseline to Week 12. Higher values indicate better cardiorespiratory fitness.
Time frame
Baseline and Week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Seoul St. Mary's Hospital
Lead sponsor
Samsung Medical Center
Collaborator
Source ClinicalTrials.gov