ClinicalTrials.gov record NCT07240844

Enavogliflozin for the Management of Patients With Amyloid CardiomyopaThy

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Enavogliflozin for the Management of Patients With Amyloid CardiomyopaThy - A Randomized, Double-Blind, Placebo-Controlled, Crossover, Multicenter Trial

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 4A study of a treatment that is already approved, to learn more about its long-term effects, safety or use in everyday practice.
Age19 years old and older
SexAll
LocationSouth Korea
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized, double-blind, placebo-controlled crossover trial tests enavogliflozin 0.3 mg in people with amyloid cardiomyopathy and symptomatic heart failure (NYHA II–III). Each participant takes the active drug for 12 weeks and placebo for 12 weeks, separated by a 4-week washout, with assessments at baseline and week 12 of each treatment period. The main measure is change in patient-reported symptoms and function (KCCQ Clinical Summary Score).

What it is studying. The study is testing the safety and effectiveness of enavogliflozin 0.3 mg compared with placebo in people with amyloid cardiomyopathy. The primary focus is change in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) after 12 weeks of treatment. Secondary measurements include exercise capacity, NT‑proBNP levels, body weight and composition, fluid status, and occurrence of worsening heart failure events or death.

What the researchers hope to learn. To evaluate the safety and effectiveness of enavogliflozin 0.3 mg in amyloid cardiomyopathy; to measure change in KCCQ-CSS; and to assess effects on exercise capacity, NT‑proBNP, body weight and composition, extracellular water ratio, and rates of worsening heart failure events or death.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Enavogliflozin 0.3mg
  • Placebo

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 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

Exclusion criteria

  • Pregnant or breastfeeding women
  • Active infection
  • Major cardiovascular events (e.g., myocardial infarction, stroke) within the past 6 months
  • Scheduled for coronary revascularization, CRT-D implantation, atrial flutter/fibrillation ablation, or valve surgery
  • History of heart transplantation
  • Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m² (calculated by CKD-EPI formula)
  • 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
  • Systolic blood pressure < 80 mmHg or symptomatic hypotension
  • Major surgery within 90 days prior to enrollment
  • Known hypersensitivity or allergic reaction to the study drug or its components
  • Moderate to severe liver impairment
  • Chronic alcohol or substance abuse
  • Residing in long-term care facilities (e.g., nursing homes)
  • 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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

Patients with a confirmed diagnosis of cardiac amyloidosis and symptomatic heart failure (NYHA class II-III) will be recruited. Participants will be randomized to receive either the study drug or placebo and will undergo baseline and 12-week assessments, including the Kansas City Cardiomyopathy Questionnaire (KCCQ), 6-minute walk test, and cardiopulmonary exercise testing. Following a 4-week washout period, participants will cross over to the alternate treatment arm (study drug or placebo) and repeat the same assessments at baseline and 12 weeks. The primary endpoint will be the change in KCCQ Clinical Summary Score (KCCQ-CSS).

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants are randomized and double‑blinded: they will take enavogliflozin 0.3 mg once daily for one 12‑week period and placebo once daily for the other 12‑week period, with a 4‑week washout between periods. At the start and end of each 12‑week period they will complete the Kansas City Cardiomyopathy Questionnaire, do a 6‑minute walk test and cardiopulmonary exercise testing, and provide blood samples and body measurements. The study team will monitor symptoms and safety throughout the two treatment periods and washout.

How the study is structured. Randomized, double-blind, placebo-controlled crossover trial. Participants are assigned to take either enavogliflozin 0.3 mg once daily or matching placebo for 12 weeks, then after a 4-week washout switch to the other treatment for another 12 weeks. Key assessments at the start and end of each treatment period include a heart-failure questionnaire (KCCQ), a 6‑minute walk test, and cardiopulmonary exercise testing, plus blood tests and body measurements.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • Some participants receive a placebo. How is that decided, and what happens for placebo-group participants when the study ends?
  • The listed sites are in South Korea. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on wild-type ATTR amyloidosis

This trial is also listed on this site under ATTRv amyloidosis.

Clinical trials121 trials listed for wild-type ATTR amyloidosisEvery trial the registry lists for wild-type ATTR amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in wild-type ATTR amyloidosis researchLatest monthly update: September 2026. Includes: Frailty and support needs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jan 6, 2026
Primary completion
Apr 29, 2027 (estimated)
Study completion
May 31, 2027 (estimated)
Target enrollment
68 participants (estimated)
Last updated on registry
Jun 18, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Seoul St. Mary's Hospital
Principal investigator
Jong-Chan Youn, MD, PhD, Professor
Seoul St. Mary's Hospital
Collaborators
  • Samsung Medical Center

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (2)

Terms used on this page · explanations by MedicalUpdates.ai

study drug
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
placebo
A treatment that looks like the study treatment but contains no active ingredient. Some participants receive it instead of the study treatment, usually without knowing which they got.
wash-out
A period during which a participant stops a previous treatment before starting the study treatment, so the earlier treatment does not affect the results.
biopsy
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Estimated glomerular filtration rate
A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
at screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
randomized
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
6-minute walk test
A test of how far a person can walk on a flat surface in six minutes. It is used to measure stamina and to track change over time.
treatment arm
One of the groups in a study. Each arm receives a particular intervention, comparator or no intervention, so the groups can be compared.
primary endpoint
The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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