A Phase 4 interventional study of enavogliflozin 0.3mg and enavogliflozin Placebo in Nonobstructive Hypertrophic Cardiomyopathy, sponsored by Yonsei University. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-08.
Sponsored by Yonsei University · Phase 4, Interventional, and Treatment
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.
Most of the medication used in HCM(hypertrophic cardiomyopathy) targets dynamic left ventricular obstruction and hypercontractility. Guidelines recommend that beta-blockers and calcum channels can also be used to lower heart rate and improve diastolic function in symptomatic nonobstructive HCM(hypertrophic cardiomyopathy), and that diuretics may be considered next, but there is a paucity of evidence supporting these recommendations. Left ventricular diastolic dysfunction is the main pathophysiological mechanism in nonobstructive HCM. SGLT2(Sodium-glucose transporter 2) inhibitors have been shown to reduce heart failure events and mortality in patients with heart failure with preserved ejection fraction, and have also been reported to improve left ventricular diastolic function. This study will investigate the efficacy and safety of enavogliflozin, an SGLT2(Sodium-glucose transporter 2) inhibitor, compared with placebo in patients with nonobstructive hypertrophic cardiomyopathy, over a period of 6 months.
Patients with hypertrophic cardiomyopathy and without evidence of dynamic left ventricular outflow tract obstruction at resting or on provocation by Valsalva maneuver or exercise will be enrolled. Participants will be randomly assigned to the enavogliflozin 0.3mg group and the placebo group in a 1:1 ratio and will continue the medication for 24 weeks. Changes in left ventricular diastolic reserve assessed by diastolic stress echocardiography will be compared between the treatment groups at 24 weeks. Changes in other parameters of diastolic function and exercise capacity will be assessed by diastolic stress echocardiography and compared between the treatment groups. Symptom status, serum biomarker levels, and arrhythmic burden on 24 hour ambulatory electrocardiogram will also be compared between the treatment groups. Post-trial follow-up will be performed at 52 weeks.
363 studies on the registry are indexed under Cardiomyopathy, Hypertrophic; 116 are open to participants now.
This study's planned enrollment of 200 is above the median of 60 across 180 interventional studies indexed under Cardiomyopathy, Hypertrophic.
Browse Cardiomyopathy, Hypertrophic studies →Yonsei University is the lead sponsor of 1,418 studies on the registry; 241 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with non-obstructive hypertrophic cardiomyopathy who do not show significant dynamic left ventricular outflow tract obstruction at rest or during Valsalva maneuver or exercise stress on echocardiography within 3 months of the screening visit.
Exclusion Criteria:
If you are currently taking Sodium-glucose transporter 2 (SGLT2) inhibitors or within 4 weeks
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of enavogliflozin 0.3 mg once daily or placebo.
Drug: enavogliflozin 0.3mg
Patients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of enavogliflozin 0.3 mg once daily or placebo.
Drug: enavogliflozin Placebo
Enavogliflozin 0.3mg, 1 tablet once a day, is prescribed for a period of 24 weeks. Patients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of enavogliflozin 0.3 mg once daily or placebo.
A placebo pill identical to enavogliflozin, 1 tablet once a day, is prescribed for a period of 24 weeks. Patients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of enavogliflozin 0.3 mg once daily or placebo.
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).
Time frame: 24 weeks, 52 weeks
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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 24 weeks, 52 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Nov 2026, 25 months after the start.
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Studies of the drug tested here: Enavogliflozin
Cardiomyopathy, Hypertrophic →