ENavogliflozin DElivering Alleviation of Ventricular Diastolic Dysfunction in nonObstRuctive Hypertrophic CardioMyopathy

NCT06580717 | Recruiting Phase 4 DMC

• 1 other identifier: 4-2024-0089
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nonobstructive Hypertrophic Cardiomyopathy

Keywords

non-obstructive; SGLT2; hypertrophic cardiomyopathy; HCM; ENDEAVOR-HCM; ertugliflozin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Comparison of Diastolic Stress Echocardiography Parameters

  24 weeks, 52 weeks

• Comparison of Cardiopulmonary Exercise Testing Parameters

  24 weeks, 52 weeks

• Comparison of Blood Biomarkers

  24 weeks, 52 weeks

• Comparison of Symptom Survey

  24 weeks, 52 weeks

• Comparison of Arrhythmic Burden on 24-Hour Ambulatory Electrocardiogram

  24 weeks, 52 weeks

Study Arms (2)

Enavogliflozin 0.3mg

EXPERIMENTAL

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

Enavogliflozin placebo

PLACEBO COMPARATOR

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

Interventions

enavogliflozin 0.3mg DRUG

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.

Enavogliflozin 0.3mg

enavogliflozin Placebo DRUG

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.

Enavogliflozin placebo

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A patient who understands the research protocol and fills out a consent form
• Adults over 19 years of age and under 80 years of age
• Non-diabetic or type 2 diabetic patients (HbA1c 6.5-10.5%)
• 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.
• Non-obstructive hypertrophic cardiomyopathy: corresponds to maximum left ventricular outflow tract pressure gradient \<30mmHg.
• Maximum left ventricular wall thickness ≥15mm if there is no family history of hypertrophic cardiomyopathy, or maximum left ventricular wall thickness ≥13mm if there is a family history of hypertrophic cardiomyopathy or positive for related genetic mutation.
• For hypertrophic cardiomyopathy, existing beta blockers, calcium channel blockers, diuretics and Renin-angiotension-system(RAS) blockers (beta-blocker, non-dihydropyridine Calcium Cannel Blocker, loop diuretics, thiazide and thiazide-like diuretics, mineralocorticoid receptor antagonist, angiotensin converting enzyme inhibitor/angiotensin) For patients using receptor blocker/angiotensin receptor neprilysin inhibitor), the drug dose was stable for 2 weeks before screening and no change in dose is expected throughout the study period.
• Women of childbearing age who agree to use contraception (hormones, intrauterine device, tubal ligation, spouse's vasectomy, etc.) for 30 days from the time of screening, during the clinical trial period, and after taking the clinical trial drug.
• New York Heart Association (NYHA) Class 1\~3

You may not qualify if:

• History of hypersensitivity to clinical trial drugs
• If you are currently taking Sodium-glucose transporter 2 (SGLT2) inhibitors or within 4 weeks
• \- For diabetic patients, any type of hypoglycemic agent other than Sodium-glucose transporter 2 (SGLT2) inhibitors can be used.
• Patients who cannot undergo diastolic stress echocardiography
• Patients on dialysis or with chronic renal failure with an estimated glomerular filtration rate \<30 mL/min/1.73m2
• Patients with Cardiac implantable electronic device (CIED)
• Currently pregnant or lactating
• ASpartate Transaminase(AST) or ALanine Transaminase(ALT) value more than 3 times the upper limit of normal during liver function test, history of hepatic coma, history of esophageal varices, history of porto-caval anastomosis.
• Uncontrolled hypertension (SBP≥180mmHg or DBP≥110mmHg) or severe hypotension (SBP\<90mmHg)
• Severe aortic or mitral stenosis with the possibility of surgery during the clinical trial period
• Those waiting for a heart transplant or those who have received a heart transplant
• Persons with diseases that need to be differentiated from heart failure symptoms at the investigator's discretion, such as severe anemia (hemoglobin \<7 g/dL), uncontrolled arrhythmia, severe lung disease, etc.
• If you have cancer undergoing chemotherapy/radiation/surgical treatment or if your life expectancy is expected to be less than 1 year.
• Untreated alcohol or drug abuse
• If you are participating in the administration of another clinical trial drug or clinical trial device test, or have completed participation for less than 30 days.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

Enavogliflozin

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Jiwon Seo, MD

  Gangnam Severance Hospital

  PRINCIPAL INVESTIGATOR

• Jang-Won Son, MD

  Yeungnam University Hospital

  PRINCIPAL INVESTIGATOR

• In-Cheol Kim, MD

  Keimyung University Dongsan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Researchers, research coordinators, and subjects are all blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: August 30, 2024
• Study Start: October 15, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)