Nonobstructive Hypertrophic CardiomyopathyPhase 4NCT06580717
ENavogliflozin DElivering Alleviation of Ventricular Diastolic Dysfunction in nonObstRuctive Hypertrophic CardioMyopathy
A Phase 4 study testing enavogliflozin 0.3mg in people with Nonobstructive Hypertrophic Cardiomyopathy, run by Yonsei University at 1 site in South Korea.
Trial summary
The primary objective of this study is to investigate the effect of enavogliflozin, an Sodium-glucose transporter 2 (SGLT2) inhibitor, compared with placebo on left ventricular diastolic function in patients with nonobstructive hypertrophic cardiomyopathy. 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?
- 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
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Oct 2024to 30 Nov 2026
- 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
- A patient who understands the research protocol and fills out a consent form
- Adults over 19 years of age and under 80 years of age
- Non-diabetic or type 2 diabetic patients (HbA1c 6.5-10.5%)
- Patients with non-obstructive hypertrophic cardiomyopathy who do not show significant dynamic left ventricular outflow tract obstruction at rest or during Valsalva maneuver or exercise stress on echocardiography within 3 months of the screening visit.
- Non-obstructive hypertrophic cardiomyopathy: corresponds to maximum left ventricular outflow tract pressure gradient <30mmHg.
- Maximum left ventricular wall thickness ≥15mm if there is no family history of hypertrophic cardiomyopathy, or maximum left ventricular wall thickness ≥13mm if there is a family history of hypertrophic cardiomyopathy or positive for related genetic mutation.
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- For hypertrophic cardiomyopathy, existing beta blockers, calcium channel blockers, diuretics and Renin-angiotension-system(RAS) blockers (beta-blocker, non-dihydropyridine Calcium Cannel Blocker, loop diuretics, thiazide and thiazide-like diuretics, mineralocorticoid receptor antagonist, angiotensin converting enzyme inhibitor/angiotensin) For patients using receptor blocker/angiotensin receptor neprilysin inhibitor), the drug dose was stable for 2 weeks before screening and no change in dose is expected throughout the study period.
- Women of childbearing age who agree to use contraception (hormones, intrauterine device, tubal ligation, spouse's vasectomy, etc.) for 30 days from the time of screening, during the clinical trial period, and after taking the clinical trial drug.
- New York Heart Association (NYHA) Class 1~3
Who cannot join
- History of hypersensitivity to clinical trial drugs
- If you are currently taking Sodium-glucose transporter 2 (SGLT2) inhibitors or within 4 weeks
- For diabetic patients, any type of hypoglycemic agent other than Sodium-glucose transporter 2 (SGLT2) inhibitors can be used.
- Patients who cannot undergo diastolic stress echocardiography
- Patients on dialysis or with chronic renal failure with an estimated glomerular filtration rate <30 mL/min/1.73m2
- Patients with Cardiac implantable electronic device (CIED)
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- Currently pregnant or lactating
- ASpartate Transaminase(AST) or ALanine Transaminase(ALT) value more than 3 times the upper limit of normal during liver function test, history of hepatic coma, history of esophageal varices, history of porto-caval anastomosis.
- Uncontrolled hypertension (SBP≥180mmHg or DBP≥110mmHg) or severe hypotension (SBP<90mmHg)
- Severe aortic or mitral stenosis with the possibility of surgery during the clinical trial period
- Those waiting for a heart transplant or those who have received a heart transplant
- Persons with diseases that need to be differentiated from heart failure symptoms at the investigator's discretion, such as severe anemia (hemoglobin <7 g/dL), uncontrolled arrhythmia, severe lung disease, etc.
- If you have cancer undergoing chemotherapy/radiation/surgical treatment or if your life expectancy is expected to be less than 1 year.
- Untreated alcohol or drug abuse
- If you are participating in the administration of another clinical trial drug or clinical trial device test, or have completed participation for less than 30 days.
- Patients with type 1 diabetes or diabetic ketoacidosis
- New York Heart Association (NYHA) class 4
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, 03722
Geu-Ru Hong, MD, PhD, 82-2-2228-8443, GRHONG@yuhs.ac
About this study
Official title: ENavogliflozin DElivering Alleviation of Ventricular Diastolic Dysfunction in nonObstRuctive Hypertrophic CardioMyopathy: a Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study (ENDEAVOR-HCM)
The primary objective of this study is to investigate the effect of enavogliflozin, an Sodium-glucose transporter 2 (SGLT2) inhibitor, compared with placebo on left ventricular diastolic function in patients with nonobstructive hypertrophic cardiomyopathy. The secondary objective of this study is to investigate the effect of enavogliflozin on exercise capacity, symptoms, serum biomarkers, and arrhythmic burden in patients with nonobstructive hypertrophic cardiomyopathy.
Read the detailed description
Most of the medication used in HCM(hypertrophic cardiomyopathy) targets dynamic left ventricular obstruction and hypercontractility. Guidelines recommend that beta-blockers and calcum channels can also be used to lower heart rate and improve diastolic function in symptomatic nonobstructive HCM(hypertrophic cardiomyopathy), and that diuretics may be considered next, but there is a paucity of evidence supporting these recommendations. Left ventricular diastolic dysfunction is the main pathophysiological mechanism in nonobstructive HCM. SGLT2(Sodium-glucose transporter 2) inhibitors have been shown to reduce heart failure events and mortality in patients with heart failure with preserved ejection fraction, and have also been reported to improve left ventricular diastolic function. This study will investigate the efficacy and safety of enavogliflozin, an SGLT2(Sodium-glucose transporter 2) inhibitor, compared with placebo in patients with nonobstructive hypertrophic cardiomyopathy, over a period of 6 months.
Patients with hypertrophic cardiomyopathy and without evidence of dynamic left ventricular outflow tract obstruction at resting or on provocation by Valsalva maneuver or exercise will be enrolled. Participants will be randomly assigned to the enavogliflozin 0.3mg group and the placebo group in a 1:1 ratio and will continue the medication for 24 weeks. Changes in left ventricular diastolic reserve assessed by diastolic stress echocardiography will be compared between the treatment groups at 24 weeks. Changes in other parameters of diastolic function and exercise capacity will be assessed by diastolic stress echocardiography and compared between the treatment groups. Symptom status, serum biomarker levels, and arrhythmic burden on 24 hour ambulatory electrocardiogram will also be compared between the treatment groups. Post-trial follow-up will be performed at 52 weeks.
- Being tested
- enavogliflozin 0.3mg, enavogliflozin Placebo
- Keywords
- non-obstructive, SGLT2, hypertrophic cardiomyopathy, HCM, ENDEAVOR-HCM, ertugliflozin
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enavogliflozin 0.3mgDrug
Enavogliflozin 0.3mg, 1 tablet once a day, is prescribed for a period of 24 weeks.
Patients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of enavogliflozin 0.3 mg once daily or placebo.
enavogliflozin PlaceboDrug
A placebo pill identical to enavogliflozin, 1 tablet once a day, is prescribed for a period of 24 weeks.
Patients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of enavogliflozin 0.3 mg once daily or placebo.
| Study group | Role | What they receive |
|---|---|---|
| Enavogliflozin 0.3mg | Experimental | Patients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of enavogliflozin 0.3 mg once daily or placebo. Receives: Drug: enavogliflozin 0.3mg |
| Enavogliflozin placebo | Placebo comparator | Patients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of enavogliflozin 0.3 mg once daily or placebo. Receives: Drug: enavogliflozin Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in left ventricular diastolic reserve (Δe') assessed by diastolic stress echocardiography
This variable will be assessed by diastolic stress echocardiography and compared to baseline values at 24 weeks (end of study) This variable will be assessed by diastolic stress echocardiography and compared to baseline values at 52 weeks (post-trial 24 weeks).
This variable will be assessed by diastolic stress echocardiography and compared to 24 weeks (end of study) values at 52 weeks (post-trial 24 weeks).
Measured: 24 weeks, 52 weeks
Secondary outcomes (5)
Comparison of Diastolic Stress Echocardiography Parameters
Change from enrollment to end of study in e' (cm/sec) at 52 weeks
Change from enrollment to end of study in E (m/sec) at 52 weeks
Change from enrollment to end of study in E to e' ratio at 52 weeks
Change from enrollment to end of study in pulmonary artery systolic pressure (mmHg) at 52 weeks
Change from enrollment to end of study in global longitudinal left ventricular strain (%) at 52 weeks
Change from enrollment to end of study in left atrial reservoir strain (%) at 52 weeks
Measured: 24 weeks, 52 weeks
Comparison of Cardiopulmonary Exercise Testing Parameters
Change from enrollment to end of study in peak oxygen consumption (VO2max) (ml/kg/min) at 52 weeks
Change from enrollment to end of study in VE to VCO2 slope (ratio) at 52 weeks
Change from enrollment to end of study in ventilatory anaerobic threshold (VAT) (ml/kg/min) at 52 weeks
Change from enrollment to end of study in metabolic equivalents (METs) at 52 weeks
Change from enrollment to end of study in exercise time (min) at 52 weeks
Measured: 24 weeks, 52 weeks
Comparison of Blood Biomarkers
Change from enrollment to end of study in NT-proBNP levels (pg/mL) at 52 weeks.
Change from enrollment to end of study in Troponin T levels (ng/mL) at 52 weeks.
Measured: 24 weeks, 52 weeks
Comparison of Symptom Survey
Change from enrollment to end of study in New York Heart Association (NYHA) Functional Class (Functional class I, II, III, IV) at 52 weeks
Change from enrollment to end of study in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score (0 to 100, with higher scores indicating better health.) at 52 weeks
Measured: 24 weeks, 52 weeks
Comparison of Arrhythmic Burden on 24-Hour Ambulatory Electrocardiogram
Change from enrollment to end of study in Atrial Premature Contractions(APC) burden at 52 weeks
Change from enrollment to end of study in Ventricular Premature Contractions(VPC) burden at 52 weeks
Change from enrollment to end of study in APC to VPC burden ratio (%) at 52 weeks
Change from enrollment to end of study in Standard Deviation of Normal Sinus R-R Intervals (SDNN) (ms) at 52 weeks.
Change from enrollment to end of study in root mean square of the mean of the squared differences of two consecutive R-R intervals (rMSSD) (ms) at 52 weeks.
Change from enrollment to end of study in Low Frequency(LF) to High Frequency(HF) ratio at 52 weeks.
Measured: 24 weeks, 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start15 Oct 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (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
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiwon Seo, MD, Principal investigator, Gangnam Severance HospitalJang-Won Son, MD, Principal investigator, Yeungnam University HospitalIn-Cheol Kim, MD, Principal investigator, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580717
- Sponsor's protocol ID
- 4-2024-0089
- Status last verified
- Nov 2024
- First submitted
- 25 Mar 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENavogliflozin DElivering Alleviation of Ventricular Diastolic Dysfunction in nonObstRuctive Hypertrophic CardioMyopathy: a Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study (ENDEAVOR-HCM)
- ClinicalTrials.gov ID
- NCT06580717
- Acronym / sponsor ID
- 4-2024-0089
- Keywords
- non-obstructive, SGLT2, hypertrophic cardiomyopathy, HCM, ENDEAVOR-HCM, ertugliflozin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 30 Aug 2024 (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.
The primary objective of this study is to investigate the effect of enavogliflozin, an Sodium-glucose transporter 2 (SGLT2) inhibitor, compared with placebo on left ventricular diastolic function in patients with nonobstructive hypertrophic cardiomyopathy. The secondary objective of this study is to investigate the effect of enavogliflozin on exercise capacity, symptoms, serum biomarkers, and arrhythmic burden in patients with nonobstructive hypertrophic cardiomyopathy.
Detailed description
Most of the medication used in HCM(hypertrophic cardiomyopathy) targets dynamic left ventricular obstruction and hypercontractility. Guidelines recommend that beta-blockers and calcum channels can also be used to lower heart rate and improve diastolic function in symptomatic nonobstructive HCM(hypertrophic cardiomyopathy), and that diuretics may be considered next, but there is a paucity of evidence supporting these recommendations. Left ventricular diastolic dysfunction is the main pathophysiological mechanism in nonobstructive HCM. SGLT2(Sodium-glucose transporter 2) inhibitors have been shown to reduce heart failure events and mortality in patients with heart failure with preserved ejection fraction, and have also been reported to improve left ventricular diastolic function. This study will investigate the efficacy and safety of enavogliflozin, an SGLT2(Sodium-glucose transporter 2) inhibitor, compared with placebo in patients with nonobstructive hypertrophic cardiomyopathy, over a period of 6 months.
Patients with hypertrophic cardiomyopathy and without evidence of dynamic left ventricular outflow tract obstruction at resting or on provocation by Valsalva maneuver or exercise will be enrolled. Participants will be randomly assigned to the enavogliflozin 0.3mg group and the placebo group in a 1:1 ratio and will continue the medication for 24 weeks. Changes in left ventricular diastolic reserve assessed by diastolic stress echocardiography will be compared between the treatment groups at 24 weeks. Changes in other parameters of diastolic function and exercise capacity will be assessed by diastolic stress echocardiography and compared between the treatment groups. Symptom status, serum biomarker levels, and arrhythmic burden on 24 hour ambulatory electrocardiogram will also be compared between the treatment groups. Post-trial follow-up will be performed at 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enavogliflozin 0.3mg | Experimental | Drug: enavogliflozin 0.3mgPatients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of enavogliflozin 0.3 mg once daily or placebo. |
| Enavogliflozin placebo | Placebo comparator | Drug: enavogliflozin PlaceboPatients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of enavogliflozin 0.3 mg once daily or placebo. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- A patient who understands the research protocol and fills out a consent form
- Adults over 19 years of age and under 80 years of age
- Non-diabetic or type 2 diabetic patients (HbA1c 6.5-10.5%)
- Patients with non-obstructive hypertrophic cardiomyopathy who do not show significant dynamic left ventricular outflow tract obstruction at rest or during Valsalva maneuver or exercise stress on echocardiography within 3 months of the screening visit.
- For hypertrophic cardiomyopathy, existing beta blockers, calcium channel blockers, diuretics and Renin-angiotension-system(RAS) blockers (beta-blocker, non-dihydropyridine Calcium Cannel Blocker, loop diuretics, thiazide and thiazide-like diuretics, mineralocorticoid receptor antagonist, angiotensin converting enzyme inhibitor/angiotensin) For patients using receptor blocker/angiotensin receptor neprilysin inhibitor), the drug dose was stable for 2 weeks before screening and no change in dose is expected throughout the study period.
Key exclusion criteria (17 listed)
- History of hypersensitivity to clinical trial drugs
- If you are currently taking Sodium-glucose transporter 2 (SGLT2) inhibitors or within 4 weeks
- Patients who cannot undergo diastolic stress echocardiography
- Patients on dialysis or with chronic renal failure with an estimated glomerular filtration rate <30 mL/min/1.73m2
- Patients with Cardiac implantable electronic device (CIED)
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 0.3mgEnavogliflozin 0.3mg, 1 tablet once a day, is prescribed for a period of 24 weeks. Patients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of enavogliflozin 0.3 mg once daily or placebo. | Drug | Enavogliflozin 0.3mg |
| enavogliflozin PlaceboA placebo pill identical to enavogliflozin, 1 tablet once a day, is prescribed for a period of 24 weeks. Patients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of enavogliflozin 0.3 mg once daily or placebo. | Drug | Enavogliflozin placebo |
Primary outcome
Change from baseline in left ventricular diastolic reserve (Δe') assessed by diastolic stress echocardiography
Time frame: 24 weeks, 52 weeks
This variable will be assessed by diastolic stress echocardiography and compared to baseline values at 24 weeks (end of study) This variable will be assessed by diastolic stress echocardiography and compared to baseline values at 52 weeks (post-trial 24 weeks). This variable will be assessed by diastolic stress echocardiography and compared to 24 weeks (end of study) values at 52 weeks (post-trial 24 weeks).
5 secondary outcomes
Comparison of Diastolic Stress Echocardiography Parameters
Time frame: 24 weeks, 52 weeks
Comparison of Cardiopulmonary Exercise Testing Parameters
Time frame: 24 weeks, 52 weeks
Comparison of Blood Biomarkers
Time frame: 24 weeks, 52 weeks
Comparison of Symptom Survey
Time frame: 24 weeks, 52 weeks
Comparison of Arrhythmic Burden on 24-Hour Ambulatory Electrocardiogram
Time frame: 24 weeks, 52 weeks
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 8 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, South Korea
Jiwon Seo, MD principal investigator
Gangnam Severance Hospital
Jang-Won Son, MD principal investigator
Yeungnam University Hospital
In-Cheol Kim, MD principal investigator
Keimyung University Dongsan Medical Center
1 site 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 Nonobstructive Hypertrophic Cardiomyopathy, run by Yonsei University at 1 site 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 9 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 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in left ventricular diastolic reserve (Δe') assessed by diastolic stress echocardiography (time frame: 24 weeks, 52 weeks). 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 8 Nov 2024.