What is Enavogliflozin studying for patients with severe aortic stenosis and heart failure?

Enavogliflozin is being studied to see if it can reduce major cardiovascular events and hospital visits for heart failure in patients who have severe aortic stenosis and underwent transcatheter aortic valve replacement. This research is led by Dr. Duk-Woo Park to evaluate the drug's effects compared to a placebo alongside standard care.

Who may be eligible for this heart failure clinical trial?

Adults aged 19 or older with symptomatic severe aortic stenosis who underwent successful transcatheter aortic valve replacement and have heart failure with preserved or mildly reduced ejection fraction may be eligible. The trial includes all genders and excludes those with recent stroke or ongoing use of similar drugs. Please review eligibility criteria for more details.

Is there any cost to participate in this heart failure clinical trial?

Study-related care, including the study drug or placebo and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should be prepared for potential travel costs.

Actively Recruiting

Phase 4

Age: 19Years +

All Genders

ID05672836

Study of Enavogliflozin to Reduce Heart and Vascular Events After Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis and Heart Failure With Preserved Ejection Fraction

Led by Duk-Woo Park, MD · Updated on 2026-06-29

1040

Participants Needed

Research Sites

17 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying whether a new drug called Enavogliflozin, taken once daily at 0.3 mg, can better reduce major heart problems and heart failure events compared to a placebo. The study focuses on adults aged 19 and older who have severe aortic stenosis and heart failure with preserved ejection fraction, and who have undergone transcatheter aortic valve replacement TAVR. Participants are randomly assigned to receive either Enavogliflozin or a placebo once daily, along with their usual medical care. The trial compares the effects of these treatments over 12 months to see if Enavogliflozin can reduce heart-related events and hospitalizations for heart failure. The study is double-blind and placebo-controlled, meaning neither participants nor researchers know who is receiving the drug or placebo. During the study, participants will be monitored regularly for heart health, including heart function via echocardiography, blood tests for heart biomarkers, and questionnaires about symptoms and quality of life. Researchers will track major heart events, hospital stays, kidney health, and safety outcomes over one year. The total study duration spans several years, with the primary outcome assessed at 12 months after starting the treatment.

CONDITIONS

Brief Title

ENAVOgliflozin Outcome Trial in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement

Who Can Participate

Age: 19Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patients aged 19 years or older with symptomatic aortic stenosis who had successful transcatheter aortic valve replacement
Successful TAVR defined by proper prosthetic valve positioning, intended valve performance, and absence of major complications
Heart failure with mildly reduced or preserved ejection fraction (LVEF ≥40%) and structural heart disease (left ventricular hypertrophy or left atrial enlargement)
NT-proBNP levels ≥300 pg/mL without atrial fibrillation or ≥600 pg/mL with ongoing atrial fibrillation
Voluntary written informed consent to participate

You will not qualify if you...

Acute decompensated heart failure requiring intravenous treatment or mechanical support after TAVR
Use of SGLT2 inhibitors within 4 weeks before randomization
Known allergy or intolerance to SGLT2 inhibitors
Heart failure with reduced ejection fraction (LVEF <40%)
Type 1 diabetes mellitus or diabetic ketoacidosis
Chronic cystitis or recurrent urinary tract infections (≥2 times in 1 year)
Stroke or transient ischemic attack within 12 weeks before enrollment
Persistent symptomatic hypotension or systolic blood pressure <95 mmHg at screening or randomization
Systolic blood pressure ≥180 mmHg or ≥160 mmHg with ≥3 antihypertensive drugs
Heart failure due to infiltrative cardiomyopathy, myocarditis, constrictive pericarditis, tamponade, hypertrophic obstructive cardiomyopathy, ARVD, or uncorrected primary valvular disease
Severe renal insufficiency (eGFR <30 ml/min/1.73 m2) or dialysis
Severe liver disease or elevated liver enzymes
Chronic pulmonary disease requiring oxygen or steroids or recent hospitalization
Current or suspected malignancy within 5 years
Uncontrolled anemia or hemoglobin <9 g/dl
Uncontrolled hypothyroidism, arrhythmia, or tachycardia
Active alcohol or drug addiction
Non-cardiac comorbidities with life expectancy less than 12 months
Planned major high-risk surgery after TAVR
Women of childbearing age not using effective contraception, pregnancy, or breastfeeding
Participation in other clinical trials except under specific conditions

Research Team

Jeong-youn Bae, Project manager

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Study of Enavogliflozin to Reduce Heart and Vascular Events After Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis and Heart Failure With Preserved Ejection Fraction

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria