Nonobstructive Hypertrophic CardiomyopathyPhase 4DAPA-HCMNCT07897500
Dapagliflozin in Patients With Non-Obstructive Hypertrophic Cardiomyopathy: A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
A Phase 4 study testing Dapagliflozin 10mg in people with Nonobstructive Hypertrophic Cardiomyopathy, run by Yonsei University.
Trial summary
This study is a prospective, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of dapagliflozin in patients with nonobstructive hypertrophic cardiomyopathy (HCM). Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Nonobstructive Hypertrophic Cardiomyopathy
- What is being tested?
- Dapagliflozin 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2027to 26 Apr 2030
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand the study protocol and provide written informed consent.
- Adults aged 19 to 80 years.
- Nondiabetic participants or participants with type 2 diabetes mellitus (HbA1c 6.5% to 10.5%).
- Patients with nonobstructive hypertrophic cardiomyopathy (HCM) documented by echocardiography performed within 3 months prior to screening, with no significant dynamic left ventricular outflow tract (LVOT) obstruction at rest, during the Valsalva maneuver, or with exercise provocation.
- Nonobstructive HCM defined as a maximum LVOT pressure gradient <30 mmHg.
- Maximum left ventricular wall thickness ≥15 mm in participants without a family history of HCM, or ≥13 mm in participants with a family history of HCM or a pathogenic HCM-associated genetic variant.
- Participants receiving medical therapy for HCM, including beta-blockers, non-dihydropyridine calcium channel blockers, loop diuretics, thiazide or thiazide-like diuretics, mineralocorticoid receptor antagonists, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, or angiotensin receptor-neprilysin inhibitors, must have been on a stable dose for at least 2 weeks prior to randomization and be expected to remain on a stable dose throughout the study period.
- Women of childbearing potential who agree to use effective contraception
Who cannot join
- History of hypersensitivity to the investigational product.
- Current treatment with an SGLT2 inhibitor or use within 4 weeks prior to screening. (For participants with diabetes mellitus, use of glucose-lowering medications other than SGLT2 inhibitors is permitted.)
- Inability to perform cardiopulmonary exercise testing (CPET).
- End-stage renal disease requiring dialysis or chronic kidney disease with estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m².
- Presence of a cardiac implantable electronic device (CIED), except for an implantable cardioverter-defibrillator (ICD) implanted at least 3 months before informed consent.
- Current pregnancy or breastfeeding.
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- AST or ALT >3 times the upper limit of normal, history of hepatic encephalopathy, esophageal varices, or portocaval shunt surgery.
- Uncontrolled hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg) or severe hypotension (systolic blood pressure <90 mmHg).
- Severe aortic stenosis or mitral stenosis with a potential need for surgical intervention during the study period.
- Candidates for heart transplantation or recipients of a previous heart transplantation.
- Conditions that may confound the assessment of heart failure symptoms, including severe anemia (hemoglobin <7 g/dL), uncontrolled arrhythmias, severe pulmonary disease, or other conditions judged by the investigator to interfere with study assessments.
- Active malignancy receiving chemotherapy, radiation therapy, or surgical treatment, or life expectancy of less than 1 year.
- Untreated alcohol abuse or substance abuse.
- Participation in another investigational drug or medical device study, or participation in such a study within 30 days prior to screening.
- Type 1 diabetes mellitus or history of diabetic ketoacidosis.
- New York Heart Association (NYHA) Class IV.
- Hereditary intolerance to lactose anhydrous, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Dapagliflozin in Patients With Non-Obstructive Hypertrophic Cardiomyopathy: A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial (DAPA-HCM)
This study is a prospective, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of dapagliflozin in patients with nonobstructive hypertrophic cardiomyopathy (HCM).
Patients with nonobstructive HCM frequently experience exercise intolerance, heart failure symptoms, and impaired quality of life due to diastolic dysfunction and myocardial remodeling. However, effective disease-modifying treatment options remain limited. Sodium-glucose cotransporter 2 (SGLT2) inhibitors have demonstrated clinical benefits in patients with heart failure and may improve myocardial relaxation, cardiac remodeling, and exercise capacity.
Approximately 440 patients with nonobstructive HCM will be randomized in a 1:1 ratio to receive dapagliflozin 10 mg once daily or matching placebo for 24 weeks. The primary objective is to evaluate the effect of dapagliflozin on exercise capacity as measured by the change in peak oxygen consumption (peak VO₂) from baseline to Week 24. Secondary objectives include evaluation of diastolic function, echocardiographic parameters, heart failure symptoms, serum biomarkers, arrhythmic burden, and cardiac magnetic resonance imaging parameters in a predefined substudy population.
Read the detailed description
Hypertrophic cardiomyopathy (HCM) is the most common inherited cardiomyopathy and is characterized by unexplained left ventricular hypertrophy in the absence of abnormal loading conditions. Patients with nonobstructive HCM frequently experience exercise intolerance, dyspnea, and heart failure symptoms despite preserved left ventricular ejection fraction. Impaired left ventricular relaxation and elevated filling pressures are important pathophysiological mechanisms contributing to symptoms and disease progression.
Sodium-glucose cotransporter-2 (SGLT2) inhibitors have demonstrated beneficial cardiovascular effects in patients with heart failure, including improvements in cardiac function, myocardial remodeling, and clinical outcomes. However, the effects of SGLT2 inhibition in patients with nonobstructive HCM have not been adequately investigated.
This study is designed to evaluate the efficacy and safety of enavogliflozin compared with placebo in patients with nonobstructive hypertrophic cardiomyopathy. Eligible participants will be randomized to receive either enavogliflozin or matching placebo in addition to standard medical therapy.
The primary objective is to assess the effect of enavogliflozin on left ventricular diastolic function. Secondary objectives include evaluation of exercise capacity, symptoms, serum biomarkers, and arrhythmic burden. Clinical assessments, laboratory testing, electrocardiography, ambulatory rhythm monitoring, cardiopulmonary exercise testing, and echocardiographic examinations will be performed according to the study schedule to evaluate treatment effects.
The results of this study are expected to provide evidence regarding the potential role of SGLT2 inhibition as a therapeutic strategy for patients with nonobstructive hypertrophic cardiomyopathy.
- Being tested
- Dapagliflozin 10mg, Dapagliflozin Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10mgDrug
Dapagliflozin 10 mg film-coated tablet administered orally once daily after breakfast for 24 weeks.
Dapagliflozin PlaceboDrug
Matching placebo film-coated tablet administered orally once daily after breakfast for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin 10mg | Experimental | Participants randomized to the experimental arm will receive dapagliflozin 10 mg orally once daily after breakfast for 24 weeks in addition to standard medical therapy for nonobstructive hypertrophic cardiomyopathy. Receives: Drug: Dapagliflozin 10mg |
| Dapagliflozin Placebo | Placebo comparator | Participants randomized to the control arm will receive matching placebo orally once daily after breakfast for 24 weeks in addition to standard medical therapy for nonobstructive hypertrophic cardiomyopathy. Receives: Drug: Dapagliflozin Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Peak Oxygen Consumption (Peak VO₂) at Week 24
Exercise capacity will be assessed by cardiopulmonary exercise testing (CPET). The primary endpoint is the change from baseline to Week 24 in peak oxygen consumption (peak VO₂, mL/kg/min).
Measured: Baseline and Week 24
Secondary outcomes (6)
Change From Baseline in Cardiopulmonary Exercise Testing Parameters at Week 24
Change From Baseline in Cardiopulmonary Exercise Testing Parameters at Week 24
- Proportion of Participants Achieving an Improvement of at Least 1.5 mL/kg/min in Peak VO₂ (%) at Week 24
- Change From Baseline in Metabolic Equivalents (METs) at Week 24
- Change From Baseline in Exercise Duration (min) at Week 24
- Change From Baseline in Ventilatory Efficiency (VE/VCO₂ Ratio) at Week 24
- Change From Baseline in Ventilatory Anaerobic Threshold (VAT, mL/kg/min) at Week 24
Measured: Baseline and Week 24
Change From Baseline in Echocardiographic Parameters at Week 24
Change From Baseline in Echocardiographic Parameters at Week 24
- Change From Baseline in Left Ventricular Global Longitudinal Strain (%) at Week 24
- Change From Baseline in Left Atrial Reservoir Strain (%) at Week 24
- Change From Baseline in Septal e' Velocity (cm/s) at Week 24
- Change From Baseline in E/e' Ratio at Week 24
- Change From Baseline in Pulmonary Artery Systolic Pressure (PASP, mmHg) at Week 24
- Change From Baseline in Left Ventricular Mass Index by Echocardiography (g/m²) at Week 24
- Change From Baseline in Left Ventricular End-Diastolic Dimension (mm) at Week 24
- Change From Baseline in Left Atrial Dimension (mm) at Week 24
Measured: Baseline and Week 24
Change From Baseline in Blood Biomarkers at Week 24
Change From Baseline in Blood Biomarkers at Week 24
- Change From Baseline in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP, pg/mL) at Week 24
- Change From Baseline in Troponin T (pg/mL) at Week 24
Measured: Baseline and Week 24
Change From Baseline in Symptoms and Health Status at Week 24
Change From Baseline in Symptoms at Week 24
- Change From Baseline in New York Heart Association (NYHA) Functional Class (Class I-IV) at Week 24
- Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score (points) at Week 24
Measured: Baseline and Week 24
Change From Baseline in Arrhythmic Burden on 24-Hour Ambulatory Electrocardiography at Week 24
Change From Baseline in Arrhythmic Burden Assessed by 24-Hour Ambulatory Electrocardiography at Week 24
- Change From Baseline in APC Burden (%) at Week 24
- Change From Baseline in VPC Burden (%) at Week 24
Measured: Baseline and Week 24
Change From Baseline in Cardiac Magnetic Resonance Imaging Parameters at Week 24
Change From Baseline in Cardiac Magnetic Resonance Imaging Parameters at Week 24(Severance Hospital substudy only)
Measured: Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start2 Jan 2027 (estimated)
- Primary completion1 Jul 2029 (estimated)
- Study completion26 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonobstructive Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897500
- Sponsor's protocol ID
- 4-2026-1039
- Acronym
- DAPA-HCM
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dapagliflozin in Patients With Non-Obstructive Hypertrophic Cardiomyopathy: A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial (DAPA-HCM)
- ClinicalTrials.gov ID
- NCT07897500
- Acronym / sponsor ID
- DAPA-HCM / 4-2026-1039
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 2 Jan 2027 (estimated)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 26 Apr 2030 (estimated)
- First posted
- 27 Oct 2026 (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 is a prospective, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of dapagliflozin in patients with nonobstructive hypertrophic cardiomyopathy (HCM).
Patients with nonobstructive HCM frequently experience exercise intolerance, heart failure symptoms, and impaired quality of life due to diastolic dysfunction and myocardial remodeling. However, effective disease-modifying treatment options remain limited. Sodium-glucose cotransporter 2 (SGLT2) inhibitors have demonstrated clinical benefits in patients with heart failure and may improve myocardial relaxation, cardiac remodeling, and exercise capacity.
Approximately 440 patients with nonobstructive HCM will be randomized in a 1:1 ratio to receive dapagliflozin 10 mg once daily or matching placebo for 24 weeks. The primary objective is to evaluate the effect of dapagliflozin on exercise capacity as measured by the change in peak oxygen consumption (peak VO₂) from baseline to Week 24. Secondary objectives include evaluation of diastolic function, echocardiographic parameters, heart failure symptoms, serum biomarkers, arrhythmic burden, and cardiac magnetic resonance imaging parameters in a predefined substudy population.
Detailed description
Hypertrophic cardiomyopathy (HCM) is the most common inherited cardiomyopathy and is characterized by unexplained left ventricular hypertrophy in the absence of abnormal loading conditions. Patients with nonobstructive HCM frequently experience exercise intolerance, dyspnea, and heart failure symptoms despite preserved left ventricular ejection fraction. Impaired left ventricular relaxation and elevated filling pressures are important pathophysiological mechanisms contributing to symptoms and disease progression.
Sodium-glucose cotransporter-2 (SGLT2) inhibitors have demonstrated beneficial cardiovascular effects in patients with heart failure, including improvements in cardiac function, myocardial remodeling, and clinical outcomes. However, the effects of SGLT2 inhibition in patients with nonobstructive HCM have not been adequately investigated.
This study is designed to evaluate the efficacy and safety of enavogliflozin compared with placebo in patients with nonobstructive hypertrophic cardiomyopathy. Eligible participants will be randomized to receive either enavogliflozin or matching placebo in addition to standard medical therapy.
The primary objective is to assess the effect of enavogliflozin on left ventricular diastolic function. Secondary objectives include evaluation of exercise capacity, symptoms, serum biomarkers, and arrhythmic burden. Clinical assessments, laboratory testing, electrocardiography, ambulatory rhythm monitoring, cardiopulmonary exercise testing, and echocardiographic examinations will be performed according to the study schedule to evaluate treatment effects.
The results of this study are expected to provide evidence regarding the potential role of SGLT2 inhibition as a therapeutic strategy for patients with nonobstructive hypertrophic cardiomyopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin 10mg | Experimental | Drug: Dapagliflozin 10mgParticipants randomized to the experimental arm will receive dapagliflozin 10 mg orally once daily after breakfast for 24 weeks in addition to standard medical therapy for nonobstructive hypertrophic cardiomyopathy. |
| Dapagliflozin Placebo | Placebo comparator | Drug: Dapagliflozin PlaceboParticipants randomized to the control arm will receive matching placebo orally once daily after breakfast for 24 weeks in addition to standard medical therapy for nonobstructive hypertrophic cardiomyopathy. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able to understand the study protocol and provide written informed consent.
- Adults aged 19 to 80 years.
- Nondiabetic participants or participants with type 2 diabetes mellitus (HbA1c 6.5% to 10.5%).
- Patients with nonobstructive hypertrophic cardiomyopathy (HCM) documented by echocardiography performed within 3 months prior to screening, with no significant dynamic left ventricular outflow tract (LVOT) obstruction at rest, during the Valsalva maneuver, or with exercise provocation.
- Participants receiving medical therapy for HCM, including beta-blockers, non-dihydropyridine calcium channel blockers, loop diuretics, thiazide or thiazide-like diuretics, mineralocorticoid receptor antagonists, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, or angiotensin receptor-neprilysin inhibitors, must have been on a stable dose for at least 2 weeks prior to randomization and be expected to remain on a stable dose throughout the study period.
Key exclusion criteria (17 listed)
- History of hypersensitivity to the investigational product.
- Current treatment with an SGLT2 inhibitor or use within 4 weeks prior to screening. (For participants with diabetes mellitus, use of glucose-lowering medications other than SGLT2 inhibitors is permitted.)
- Inability to perform cardiopulmonary exercise testing (CPET).
- End-stage renal disease requiring dialysis or chronic kidney disease with estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m².
- Presence of a cardiac implantable electronic device (CIED), except for an implantable cardioverter-defibrillator (ICD) implanted at least 3 months before informed consent.
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 |
|---|---|---|
| Dapagliflozin 10mgDapagliflozin 10 mg film-coated tablet administered orally once daily after breakfast for 24 weeks. | Drug | Dapagliflozin 10mg |
| Dapagliflozin PlaceboMatching placebo film-coated tablet administered orally once daily after breakfast for 24 weeks. | Drug | Dapagliflozin Placebo |
Primary outcome
Change From Baseline in Peak Oxygen Consumption (Peak VO₂) at Week 24
Time frame: Baseline and Week 24
Exercise capacity will be assessed by cardiopulmonary exercise testing (CPET). The primary endpoint is the change from baseline to Week 24 in peak oxygen consumption (peak VO₂, mL/kg/min).
6 secondary outcomes
Change From Baseline in Cardiopulmonary Exercise Testing Parameters at Week 24
Time frame: Baseline and Week 24
Change From Baseline in Echocardiographic Parameters at Week 24
Time frame: Baseline and Week 24
Change From Baseline in Blood Biomarkers at Week 24
Time frame: Baseline and Week 24
Change From Baseline in Symptoms and Health Status at Week 24
Time frame: Baseline and Week 24
Change From Baseline in Arrhythmic Burden on 24-Hour Ambulatory Electrocardiography at Week 24
Time frame: Baseline and Week 24
Change From Baseline in Cardiac Magnetic Resonance Imaging Parameters at Week 24
Time frame: Baseline and Week 24
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 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin 10mg in people with Nonobstructive Hypertrophic Cardiomyopathy, run by Yonsei University.
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 8 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: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Geu-Ru Hong, Professor (+82-2-2228-8304, grhong@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Peak Oxygen Consumption (Peak VO₂) at Week 24 (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2026.