Enavogliflozin for Amyloid Cardiomyopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 4, randomized, double-period crossover trial to evaluate safety and effectiveness of Enavogliflozin 0.3 mg in adults with amyloid cardiomyopathy and NYHA class II-III heart failure. Participants receive the study drug and placebo in two 12-week periods separated by a 4-week washout, with assessments at baseline and end of each period including KCCQ scores, a 6-minute walk test, and cardiopulmonary exercise testing. The primary endpoint is the change in KCCQ Clinical Summary Score. Key eligibility includes confirmed amyloid cardiomyopathy, ambulatory status, and stable diuretic dosing; several exclusions apply, such as recent major cardiovascular events and reduced eGFR.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults aged 19 years or older
2. Diagnosed with amyloid cardiomyopathy confirmed by cardiac biopsy or non-invasive imaging
3. Presence of heart failure symptoms corresponding to NYHA functional class II-III
4. Patients on stable oral diuretic use, without dose changes exceeding 50% of the previous dose, for at least 2 weeks prior to study enrollment
5. Ambulatory (able to walk)
6. Able to provide written informed consent for study participation

Exclusion Criteria:

1. Pregnant or breastfeeding women
2. Active infection
3. Major cardiovascular events (e.g., myocardial infarction, stroke) within the past 6 months
4. Scheduled for coronary revascularization, CRT-D implantation, atrial flutter/fibrillation ablation, or valve surgery
5. History of heart transplantation
6. Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73 m² (calculated by CKD-EPI formula)
7. No history of cancer within the past 5 years at screening (except borderline cancers without recurrence for 2-3 years; multiple myeloma with cardiac involvement is classified as cardiac amyloidosis and is exempt)
8. Heart failure primarily caused by severe left sided valvular disease or ischemic heart disease (except if valvular disease is corrected)
9. Type 1 diabetes mellitus or insulin-dependent diabetes
10. History of ketoacidosis, complicated urinary or genital infections, or kidney stones
11. Systolic blood pressure \< 80 mmHg or symptomatic hypotension
12. Major surgery within 90 days prior to enrollment
13. Known hypersensitivity or allergic reaction to the study drug or its components
14. Moderate to severe liver impairment
15. Chronic alcohol or substance abuse
16. Residing in long-term care facilities (e.g., nursing homes)
17. Unable to understand or comply with study drug, procedures, or follow-up, or who are deemed by the investigator to be unlikely to complete the study

Where it's running

• Samsung Medical Center
  Seoul, South Korea Recruiting
• Seoul St. Mary's Hospital, The Catholic University of Korea
  Seoul, South Korea Recruiting

Study contacts

• Principal investigator: Jong-Chan Youn, MD, PhD — Seoul St. Mary's Hospital, The Catholic University of Korea
• Study coordinator: Jong-Chan Youn, MD, PhD
• Email: jong.chan.youn@gmail.com
• Phone: 82-2-3147-9853

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Acoramidis for ATTR-CM: Cardiac Imaging Study

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• Investigating genistein for treating amyloid cardiomyopathy

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• Personalized exercise program for patients with transthyretin cardiac amyloidosis

  This study is testing a personalized exercise program to see if it can help people with transthyretin cardiac amyloidosis feel stronger and improve their quality of life.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.