ClinicalTrials.gg
Sign In
Not yet recruitingNCT07897500DAPA-HCMUpdated Oct 27, 2026

Dapagliflozin in Patients With Non-Obstructive Hypertrophic Cardiomyopathy: A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

A Phase 4 interventional study of Dapagliflozin 10mg and Dapagliflozin Placebo in Nonobstructive Hypertrophic Cardiomyopathy, sponsored by Yonsei University. Not yet recruiting. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Yonsei University · Phase 4, Interventional, and Treatment

Updated Oct 27, 2026Newly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
440
Allocation
Randomized
Ages
19 Years to 80 Years
Sex
All
01

Study 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).

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.

02

Conditions studied

  • Nonobstructive Hypertrophic Cardiomyopathy
03

In context

Lead sponsor

Yonsei University is the lead sponsor of 1,417 studies on the registry; 240 are open to participants now.

Browse Yonsei University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Able to understand the study protocol and provide written informed consent.
  2. Adults aged 19 to 80 years.
  3. Nondiabetic participants or participants with type 2 diabetes mellitus (HbA1c 6.5% to 10.5%).

  4. 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.
  5. 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.
  6. Women of childbearing potential who agree to use effective contraception

Exclusion criteria

Exclusion Criteria:

  1. History of hypersensitivity to the investigational product.
  2. 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.)
  3. Inability to perform cardiopulmonary exercise testing (CPET).
  4. End-stage renal disease requiring dialysis or chronic kidney disease with estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m².
  5. Presence of a cardiac implantable electronic device (CIED), except for an implantable cardioverter-defibrillator (ICD) implanted at least 3 months before informed consent.
  6. Current pregnancy or breastfeeding.
  7. AST or ALT >3 times the upper limit of normal, history of hepatic encephalopathy, esophageal varices, or portocaval shunt surgery.
  8. Uncontrolled hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg) or severe hypotension (systolic blood pressure \<90 mmHg).
  9. Severe aortic stenosis or mitral stenosis with a potential need for surgical intervention during the study period.
  10. Candidates for heart transplantation or recipients of a previous heart transplantation.
  11. 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.
  12. Active malignancy receiving chemotherapy, radiation therapy, or surgical treatment, or life expectancy of less than 1 year.
  13. Untreated alcohol abuse or substance abuse.
  14. Participation in another investigational drug or medical device study, or participation in such a study within 30 days prior to screening.
  15. Type 1 diabetes mellitus or history of diabetic ketoacidosis.
  16. New York Heart Association (NYHA) Class IV.
  17. Hereditary intolerance to lactose anhydrous, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
440 participants (estimated)

Study arms

  • Experimental
    Dapagliflozin 10mg

    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.

    Drug: Dapagliflozin 10mg

  • Placebo comparator
    Dapagliflozin Placebo

    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.

    Drug: Dapagliflozin Placebo

Interventions

  • DrugDapagliflozin 10mg

    Dapagliflozin 10 mg film-coated tablet administered orally once daily after breakfast for 24 weeks.

  • DrugDapagliflozin Placebo

    Matching placebo film-coated tablet administered orally once daily after breakfast for 24 weeks.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline and Week 24

Secondary outcomes

  1. 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

    Time frame: Baseline and Week 24

  2. 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

    Time frame: Baseline and Week 24

  3. 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

    Time frame: Baseline and Week 24

  4. 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

    Time frame: Baseline and Week 24

  5. 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

    Time frame: Baseline and Week 24

  6. 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)

    Time frame: Baseline and Week 24

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2027; primary completion for Jul 2029, 29 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 11, 2026
First posted
Oct 27, 2026
StartEst.
Jan 2, 2027
Primary completionEst.
Jul 1, 2029
CompletionEst.
Apr 26, 2030
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07897500
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Oct 27, 2026
Start date
Jan 2, 2027 (estimated)
Primary completion
Jul 1, 2029 (estimated)
Completion
Apr 26, 2030 (estimated)
Last update
Oct 27, 2026

Study contacts

Geu-Ru Hong, Professor
Contact
grhong@yuhs.ac
+82-2-2228-8304

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Dapagliflozin

Other studies from this sponsor

Yonsei University →

Start the discussion