NCT07240844RecruitingPhase 4
Enavogliflozin for the Management of Patients With Amyloid CardiomyopaThy
Enavogliflozin for the Management of Patients With Amyloid CardiomyopaThy - A Randomized, Double-Blind, Placebo-Controlled, Crossover, Multicenter Trial
Source: ClinicalTrials.gov · Last updated 18 Jun 2026
Brief summary (registry, in English)
This study aims to evaluate the safety and effectiveness of Enavogliflozin 0.3 mg, an SGLT2 inhibitor, in patients with amyloid cardiomyopathy. Participants will take both the study drug and a placebo in two separate periods, with a wash-out period in between. The goal is to determine whether Enavogliflozin is safe and effective for treating amyloid cardiomyopathy.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 68 (estimated)
- First submitted
- 28 Sept 2025
- Start date
- Jan 2026
- Primary completion date
- Apr 2027
- Lead sponsor
- Seoul St. Mary's Hospital
- NCT number
- NCT07240844
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 68
- From Jan 2026 to the primary completion date, Apr 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Scheduled for coronary revascularization, CRT-D implantation, atrial flutter/fibrillation ablation, or valve surgery
- Major surgery within 90 days prior to enrollment
- 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
Other illness
- Active infection
- Major cardiovascular events (e.g., myocardial infarction, stroke) within the past 6 months
- History of heart transplantation
- 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)
- Heart failure primarily caused by severe left sided valvular disease or ischemic heart disease (except if valvular disease is corrected)
- Type 1 diabetes mellitus or insulin-dependent diabetes
- History of ketoacidosis, complicated urinary or genital infections, or kidney stones
- Known hypersensitivity or allergic reaction to the study drug or its components
- Moderate to severe liver impairment
Lab values
- Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73 m² (calculated by CKD-EPI formula)
Other
- Pregnant or breastfeeding women
- Systolic blood pressure \< 80 mmHg or symptomatic hypotension
- Chronic alcohol or substance abuse
- Residing in long-term care facilities (e.g., nursing homes)
Who the study is looking for
- Adults aged 19 years or older
- Diagnosed with amyloid cardiomyopathy confirmed by cardiac biopsy or non-invasive imaging
- Presence of heart failure symptoms corresponding to NYHA functional class II-III
- Patients on stable oral diuretic use, without dose changes exceeding 50% of the previous dose, for at least 2 weeks prior to study enrollment
- Ambulatory (able to walk)
- Able to provide written informed consent for study participation
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul St. Mary's Hospital, The Catholic University of Korea Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.