Amyloid CardiomyopathyPhase 4EMPACTNCT07240844
Enavogliflozin for the Management of Patients With Amyloid CardiomyopaThy
A Phase 4 study testing Enavogliflozin 0.3mg in people with Amyloid Cardiomyopathy, run by Seoul St. Mary's Hospital at 2 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Amyloid Cardiomyopathy
- What is being tested?
- Enavogliflozin 0.3mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 6 Jan 2026to 31 May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea2 sites, 2 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Jin-Oh Choi, MD, PhD, 82-2-3410-3419, choijean5@gmail.com
Darae Kim, MD, PhD
- Recruiting
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, 06591
Jong-Chan Youn, MD, PhD, 82-2-3147-9853, jong.chan.youn@gmail.com
Maljoung Ahn, RN, 82-2-3147-9853, cmccasc@gmail.com
About this study
Official title: Enavogliflozin for the Management of Patients With Amyloid CardiomyopaThy - A Randomized, Double-Blind, Placebo-Controlled, Crossover, Multicenter Trial
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.
Read the detailed description
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).
- Conditions
- Amyloid Cardiomyopathy
- Being tested
- Enavogliflozin 0.3mg, Placebo
- Keywords
- Amyloid Cardiomyopathy, Enavogliflozin, Sodium-Glucose Cotransporter 2 Inhibitor
- Medical subject headings
- Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enavogliflozin 0.3mgDrug
Participants will receive Enavogliflozin 0.3 mg orally once daily for 12 weeks. The drug is administered in tablet form and is taken during the first or second treatment period of a crossover design.
PlaceboDrug
Participants will receive placebo orally once daily for 12 weeks. The drug is administered in tablet form and is taken during the first or second treatment period of a crossover design.
| Study group | Role | What they receive |
|---|---|---|
| Enavogliflozin | Experimental | Administer Enavogliflozin 0.3 mg Receives: Drug: Enavogliflozin 0.3mg |
| Placebo | Placebo comparator | Administer placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in KCCQ-CSS from baseline to Week 12
Change in the Clinical Summary Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-CSS) from baseline to 12 weeks after treatment initiation.
The KCCQ-CSS is a patient-reported outcome measure that assesses symptom frequency and physical limitation in patients with heart failure.
Scores range from 0 to 100, with higher scores indicating better symptom status and physical function (i.e., better health status).
A higher change from baseline reflects an improvement in clinical status.
Measured: Baseline and Week 12
Secondary outcomes (6)
Change in 6-Minute Walk Distance
Change in distance walked in 6 minutes from baseline to Week 12. Higher distance indicates better exercise capacity.
Measured: Baseline and Week 12
Change in log-transformed NT-proBNP levels
Change in log-transformed NT-proBNP levels after 12 weeks of treatment compared to baseline
Measured: Baseline and Week 12
Change in Body Weight
Change in body weight in kilograms from baseline to Week 12
Measured: Baseline and Week 12
Change in Body Fat Percentage
Change in body fat percentage from baseline to Week 12
Measured: Baseline and Week 12
Change in Extracellular Water Ratio
Change in the ratio of extracellular water to total body water from baseline to Week 12
Measured: Baseline and Week 12
Incidence of Worsening Heart Failure Events or Death
Occurrence of worsening heart failure events (defined as emergency outpatient visit or unplanned hospitalization due to heart failure) or death
Measured: From baseline to Week 12 during each treatment period (excluding the 4-week washout period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start6 Jan 2026
- Primary completion29 Apr 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Amyloid CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, multi-center, double-blind, randomized controlled, crossover, superiority trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Medical Center
- Responsible party
- Principal investigator, Jong-Chan Youn, MD, PhD, Seoul St. Mary's Hospital
- Investigators
- Jong-Chan Youn, MD, PhD, Principal investigator, Seoul St. Mary's Hospital, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240844
- Sponsor's protocol ID
- EMPACT
- Other IDs
- KC25MIDV0449
- Acronym
- EMPACT
- Status last verified
- Jun 2026
- First submitted
- 28 Sep 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked.
Publications
Porcari A, Cappelli F, Nitsche C, Tomasoni D, Sinigiani G, Longhi S, Bordignon L, Masri A, Serenelli M, Urey M, Musumeci B, Cipriani A, Canepa M, Badr-Eslam R, Kronberger C, Chimenti C, Zampieri M, Allegro V, Razvi Y, Patel R, Ioannou A, Rauf MU, Petrie A, Whelan C, Emdin M, Metra M, Merlo M, Sinagra G, Hawkins PN, Solomon SD, Gillmore JD, Fontana M. SGLT2 Inhibitor Therapy in Patients With Transthyretin Amyloid Cardiomyopathy. J Am Coll Cardiol. 2024 Jun 18;83(24):2411-2422. doi: 10.1016/j.jacc.2024.03.429.
PubMed 38866445Packer M, Butler J, Zeller C, Pocock SJ, Brueckmann M, Ferreira JP, Filippatos G, Usman MS, Zannad F, Anker SD. Blinded Withdrawal of Long-Term Randomized Treatment With Empagliflozin or Placebo in Patients With Heart Failure. Circulation. 2023 Sep 26;148(13):1011-1022. doi: 10.1161/CIRCULATIONAHA.123.065748. Epub 2023 Aug 24.
PubMed 37621153
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enavogliflozin for the Management of Patients With Amyloid CardiomyopaThy - A Randomized, Double-Blind, Placebo-Controlled, Crossover, Multicenter Trial
- ClinicalTrials.gov ID
- NCT07240844
- Acronym / sponsor ID
- EMPACT / EMPACT
- Conditions
- Amyloid Cardiomyopathy
- Keywords
- Amyloid Cardiomyopathy, Enavogliflozin, Sodium-Glucose Cotransporter 2 Inhibitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Collaborators
- Samsung Medical Center
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- 29 Apr 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Prospective, multi-center, double-blind, randomized controlled, crossover, superiority trial
| Arm | Type | Receives |
|---|---|---|
| Enavogliflozin | Experimental | Drug: Enavogliflozin 0.3mgAdminister Enavogliflozin 0.3 mg |
| Placebo | Placebo comparator | Drug: PlaceboAdminister placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enavogliflozin 0.3mgParticipants will receive Enavogliflozin 0.3 mg orally once daily for 12 weeks. The drug is administered in tablet form and is taken during the first or second treatment period of a crossover design. | Drug | Enavogliflozin |
| PlaceboParticipants will receive placebo orally once daily for 12 weeks. The drug is administered in tablet form and is taken during the first or second treatment period of a crossover design. | Drug | Placebo |
Primary outcome
Change in KCCQ-CSS from baseline to Week 12
Time frame: Baseline and Week 12
Change in the Clinical Summary Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-CSS) from baseline to 12 weeks after treatment initiation. The KCCQ-CSS is a patient-reported outcome measure that assesses symptom frequency and physical limitation in patients with heart failure. Scores range from 0 to 100, with higher scores indicating better symptom status and physical function (i.e., better health status). A higher change from baseline reflects an improvement in clinical status.
6 secondary outcomes
Change in 6-Minute Walk Distance
Time frame: Baseline and Week 12
Change in log-transformed NT-proBNP levels
Time frame: Baseline and Week 12
Change in Body Weight
Time frame: Baseline and Week 12
Change in Body Fat Percentage
Time frame: Baseline and Week 12
Change in Extracellular Water Ratio
Time frame: Baseline and Week 12
Incidence of Worsening Heart Failure Events or Death
Time frame: From baseline to Week 12 during each treatment period (excluding the 4-week washout period)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Results publication: PubMed 38866445Porcari A, Cappelli F, Nitsche C, Tomasoni D, Sinigiani G, Longhi S, Bordignon L, Masri A, Serenelli M, Urey M, Musumeci B, Cipriani A, Canepa M, Badr-Eslam R, Kronberger C, Chimenti C, Zampieri M, Allegro V, Razvi Y, Patel R, Ioannou A, Rauf MU, Petrie A, Whelan C, Emdin M, Metra M, Merlo M, Sinagra G, Hawkins PN, Solomon SD, Gillmore JD, Fontana M. SGLT2 Inhibitor Therapy in Patients With Transthyretin Amyloid Cardiomyopathy. J Am Coll Cardiol. 2024 Jun 18;83(24):2411-2422. doi: 10.1016/j.jacc.2024.03.429.
- Results publication: PubMed 37621153Packer M, Butler J, Zeller C, Pocock SJ, Brueckmann M, Ferreira JP, Filippatos G, Usman MS, Zannad F, Anker SD. Blinded Withdrawal of Long-Term Randomized Treatment With Empagliflozin or Placebo in Patients With Heart Failure. Circulation. 2023 Sep 26;148(13):1011-1022. doi: 10.1161/CIRCULATIONAHA.123.065748. Epub 2023 Aug 24.
- Individual participant dataSharing planned: Yes. After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked.
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EPIC-ATTR: A Study to Evaluate the Effect of Eplontersen on the Transthyretin Reduction and Long-term Safety in Chinese Subjects With Transthyretin Amyloid Cardiomyopathy
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MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jong-Chan Youn, MD, PhD principal investigator
Seoul St. Mary's Hospital, The Catholic University of Korea
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enavogliflozin 0.3mg in people with Amyloid Cardiomyopathy, run by Seoul St. Mary's Hospital at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jong-Chan Youn, MD, PhD (82-2-3147-9853, jong.chan.youn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in KCCQ-CSS from baseline to Week 12 (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07240844, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.