ENavogliflozin DElivering Alleviation of Ventricular Diastolic Dysfunction in nonObstRuctive Hypertrophic CardioMyopathy
NCT Number: NCT06580717
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Nonobstructive Hypertrophic Cardiomyopathy
Interventions: DRUG: enavogliflozin 0.3mg|DRUG: enavogliflozin Placebo
Sponsor: Yonsei University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-05-01
Completion Date: 2026-11-30
Locations: Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, 03722, Korea, Republic of

Summary:
The primary objective of this study is to investigate the effect of enavogliflozin, an Sodium-glucose transporter 2 (SGLT2) inhibitor, compared with placebo on left ventricular diastolic function in patients with nonobstructive hypertrophic cardiomyopathy. The secondary objective of this study is to investigate the effect of enavogliflozin on exercise capacity, symptoms, serum biomarkers, and arrhythmic burden in patients with nonobstructive hypertrophic cardiomyopathy.

Primary Outcome Measures: Change from baseline in left ventricular diastolic reserve (Δe') assessed by diastolic stress echocardiography, This variable will be assessed by diastolic stress echocardiography and compared to baseline values at 24 weeks (end of study) This variable will be assessed by diastolic stress echocardiography and compared to baseline values at 52 weeks (post-trial 24 weeks).

This variable will be assessed by diastolic stress echocardiography and compared to 24 weeks (end of study) values at 52 weeks (post-trial 24 weeks)., 24 weeks, 52 weeks
Secondary Outcome Measures: Comparison of Diastolic Stress Echocardiography Parameters, Change from enrollment to end of study in e' (cm/sec) at 52 weeks

Change from enrollment to end of study in E (m/sec) at 52 weeks

Change from enrollment to end of study in E to e' ratio at 52 weeks

Change from enrollment to end of study in pulmonary artery systolic pressure (mmHg) at 52 weeks

Change from enrollment to end of study in global longitudinal left ventricular strain (%) at 52 weeks

Change from enrollment to end of study in left atrial reservoir strain (%) at 52 weeks, 24 weeks, 52 weeks|Comparison of Cardiopulmonary Exercise Testing Parameters, Change from enrollment to end of study in peak oxygen consumption (VO2max) (ml/kg/min) at 52 weeks

Change from enrollment to end of study in VE to VCO2 slope (ratio) at 52 weeks

Change from enrollment to end of study in ventilatory anaerobic threshold (VAT) (ml/kg/min) at 52 weeks

Change from enrollment to end of study in metabolic equivalents (METs) at 52 weeks

Change from enrollment to end of study in exercise time (min) at 52 weeks, 24 weeks, 52 weeks|Comparison of Blood Biomarkers, Change from enrollment to end of study in NT-proBNP levels (pg/mL) at 52 weeks.

Change from enrollment to end of study in Troponin T levels (ng/mL) at 52 weeks., 24 weeks, 52 weeks|Comparison of Symptom Survey, Change from enrollment to end of study in New York Heart Association (NYHA) Functional Class (Functional class I, II, III, IV) at 52 weeks

Change from enrollment to end of study in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score (0 to 100, with higher scores indicating better health.) at 52 weeks, 24 weeks, 52 weeks|Comparison of Arrhythmic Burden on 24-Hour Ambulatory Electrocardiogram, Change from enrollment to end of study in Atrial Premature Contractions(APC) burden at 52 weeks

Change from enrollment to end of study in Ventricular Premature Contractions(VPC) burden at 52 weeks

Change from enrollment to end of study in APC to VPC burden ratio (%) at 52 weeks

Change from enrollment to end of study in Standard Deviation of Normal Sinus R-R Intervals (SDNN) (ms) at 52 weeks.

Change from enrollment to end of study in root mean square of the mean of the squared differences of two consecutive R-R intervals (rMSSD) (ms) at 52 weeks.

Change from enrollment to end of study in Low Frequency(LF) to High Frequency(HF) ratio at 52 weeks., 24 weeks, 52 weeks