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Heart Failure, Preserved Ejection FractionPhase 4ENRICH-PEFNCT06350487

The Efficacy of Enavogliflozin in Heart Failure With Preserved Ejection Fraction

A Phase 4 study testing SGLT2 inhibitor in people with Heart Failure, Preserved Ejection Fraction, run by Samsung Medical Center at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of prospective, open label, single center, randomized controlled trial is to investigate the efficacy of enavogliflozin on exercise performance, diastolic dysfunction, and quality of life in patients with heart failure with preserved ejection fraction (HFpEF). Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
SGLT2 inhibitor
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
1 siteSouth Korea
Study dates
1 May 2024to 30 Jun 2026
Phase
Phase 4
Are there results?
None posted in the registry

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
  1. Inclusion Criteria:
  2. Age ≥19 2) New York Heart Association (NYHA) II-III dyspnea 3) Diagnosis of HFpEF (Exams conducted within 6 months from screening) [must satisfy all (1), (2), and (3)]
  3. Left ventricular ejection fraction (LVEF) ≥50%
  4. NT-proBNP ≥220 pg/mL or BNP ≥80 pg/mL, if in sinus rhythm NT-proBNP ≥660 pg/mL or BNP ≥240 pg/mL, if in atrial fibrillation
  5. Satisfying either noninvasive or invasive criteria I. Noninvasive: Echocardiography with at least one of the following criteria
  • LAVI ≥34 ml/m2
  • Lateral E/e' ≥9
  • LVMI ≥115 g/m2 if male or ≥95 g/m2 if female
  • LV wall thickness ≥12mm II. Invasive: LVEDP ≥16mmHg or pulmonary capillary wedge pressure(PCWP) ≥15mmHg 4) Stable/chronic ambulatory patients without hospitalization within the last 30 days due to heart failure decompensation episode 5) Patients taking heart failure medication without change for at least 3 weeks before screening
  1. Exclusion Criteria:
  2. Unwillingness or inability to comply with the procedures described in this protocol
  3. The ability to walk is, in the investigator's opinion, clearly limited by joint disease or other locomotor problems or lung diseases rather than by cardiorespiratory fitness
  4. NYHA IV dyspnea
  5. Type 1 diabetes mellitus
  6. Estimated glomerular filtration rate (eGFR) <60 ml/min/1.73m2 (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula)
  7. Anemia (Hb <7g/dL)
  8. Severe hepatic impairment (Child-Pugh class C)
  9. Acute myocardial infarction or unstable angina within 30 days before inclusion or planned coronary revascularization at the time of inclusion
  10. Significant left-sided valvular heart disease (moderate to severe stenosis and severe regurgitation)
  11. Heart failure due to any of the following: infiltrative cardiomyopathy (amyloidosis, sarcoidosis), active myocarditis, constrictive pericarditis, hypertrophic cardiomyopathy
  12. Symptomatic hypotension (systolic blood pressure <90mmHg)
  13. Severe chronic obstructive pulmonary disease (postbronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity(FVC) <70% and FEV1 <50%)
  14. Treated with sodium-glucose cotransporter-2 inhibitors (SGLT2i) within 30 days before inclusion
  15. History of diabetic ketoacidosis while in treatment with SGLT2i
  16. Recurrent genitourinary tract infections
  17. History of Hypersensitivity reaction to SGLT2i
  18. Non-cardiac co-morbid conditions are present with life expectancy <2 year or that may result in protocol non-compliance (per site investigator's medical judgment)
  19. Female patients who are currently or planning to become pregnant
  20. Female patients who are lactating
  21. Patients participating in other clinical trials

Trial locations and contacts

1 site in 1 country.

Jeong Hoon Yang, MD, PhD contact

82-2-3410-6475

jhysmc@gmail.com

David Hong, MD contact

82-2-3410-6475

hongdawi@naver.com

South Korea1 site

  • Samsung Medical Center

    Seoul, 06351

    Jeong Hoon Yang, MD, PhD, 82-2-3410-3419, jhysmc@gmail.com

    David Hong, MD, 82-2-3410-3419, hongdawi@naver.com

Other trials in South Korea

About this study

Official title: The Efficacy of Enavogliflozin on Exercise Performance and Diastolic Function in Heart Failure With Preserved Ejection Fraction: A Randomized Controlled Trial

The aim of prospective, open label, single center, randomized controlled trial is to investigate the efficacy of enavogliflozin on exercise performance, diastolic dysfunction, and quality of life in patients with heart failure with preserved ejection fraction (HFpEF).

Read the detailed description

HFpEF is a clinically heterogenous syndrome and has unique characteristics that differ from the other entities of heart failure. Cardiovascular and non-cardiovascular comorbidities are known to contribute to the pathogenesis of HFpEF, and consequently, the importance of HFpEF is increasingly emphasized as the population ages. In fact, HFpEF occurs in approximately 5% of the general population aged over 60 years and account for half of hospitalization for heart failure. Notwithstanding, no medication has been found to be effective for HFpEF. Only recently, Sodium glucose cotransporter 2 (SGLT2) inhibitors was proven effective in patients with HFpEF in two landmark trials, EMPEROR-Preserved and DELIVER trials. In both trials, SGLT2 inhibitor was consistently associated with reduced risk of composite outcome of cardiovascular death and hospitalization for heart failure. In this regard, 2023 focused update of the 2021 European Society of Cardiology (ESC) guidelines for heart failure recommends SGLT2 inhibitor as class 1A recommendation in patients with HFpEF.

Despite the solid evidence about the clinical benefit of SGLT2 inhibitor in patients with HFpEF, little is known about the mechanisms responsible for the beneficial cardiac effects of SGLT2 inhibitor. Patients with HFpEF are known to have impaired exercise and functional capacity, which lead to declined quality of life and debilitating symptoms. Along with unclear mechanisms responsible for the beneficial cardiac effect of SGLT2 inhibitor, the impacts of SGLT2 inhibitor on exercise and functional capacity in patients with HFpEF have also not been clearly evaluated. Therefore, this trial aim to evaluate the impact of SGLT2 inhibitor on exercise performance, diastolic function, and quality of life in patients with HFpEF using newly developed SGLT2 inhibitor, Enavogliflozin.

Being tested
SGLT2 inhibitor
Keywords
Heart failure with preserved ejection fraction, Sodium glucose cotransporter 2 inhibitors, Exercise performance
Medical subject headings
Heart Failure, Diastolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SGLT2 inhibitorDrug

    Also called SGLT2 inhibitor: Enavogliflozin (Brand names: Envlo tab)

    Enavogliflozin (0.3mg oral tablet once daily) will be administrated.

Study groups in NCT06350487
Study groupRoleWhat they receive
SGLT2 inhibitor groupExperimentalSGLT2 inhibitor group will receive Enavogliflozin (0.3mg oral tablet once daily).
Receives: Drug: SGLT2 inhibitor
Control groupNo interventionControl group will not receive any SGLT2 inhibitors during the study period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in peak oxygen consumption (VO2)

    Change in peak oxygen consumption (VO2) from baseline to week 24

    Measured: Week 24

Secondary outcomes (17)

  1. Change in minute ventilation to carbon dioxide output ratio (VE/VCO2 slope)

    Change in minute ventilation to carbon dioxide output ratio (VE/VCO2 slope) from baseline to week 24

    Measured: Week 24

  2. Change in Left atrial volume index (LAVI) before and after maximal exercise

    Change in LAVI before and after maximal exercise from baseline to week 24

    Measured: Week 24

  3. Change in Lateral Early diastolic transmitral filling velocity over early diastolic relaxation velocity at mitral annulus (E/e') before and after maximal exercise

    Change in Lateral E/e' before and after maximal exercise from baseline to week 24

    Measured: Week 24

  4. Change in Left ventricular mass index (LVMI) before and after maximal exercise

    Change in LVMI before and after maximal exercise from baseline to week 24

    Measured: Week 24

  5. Change in LV wall thickness before and after maximal exercise

    Change in LV wall thickness before and after maximal exercise from baseline to week 24

    Measured: Week 24

  6. Change in LV global longitudinal strain before and after maximal exercise

    Change in LV global longitudinal strain before and after maximal exercise from baseline to week 24

    Measured: Week 24

  7. Change in LA strain before and after maximal exercise

    Change in LA strain before and after maximal exercise from baseline to week 24

    Measured: Week 24

  8. Change in right ventricular (RV) free wall strain before and after maximal exercise

    Change in RV free wall strain before and after maximal exercise from baseline to week 24

    Measured: Week 24

  9. Change in health-related quality of life assessed by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS)

    Change in health-related quality of life assessed by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS) from baseline to week 24

    Score ranges from 0 to 100 and higher value represents better quality of life.

    Measured: Week 24

  10. Change in N-Terminal pro-B-type Natriuretic Peptide (NT-proBNP) level

    Change in NT-proBNP level from baseline to week 24

    Measured: Week 24

  11. Change in chronotropic response reserve assessed by change in heart rate from rest to peak exercise

    Change in chronotropic response reserve assessed by change in heart rate from rest to peak exercise from baseline to week 24

    Measured: Week 24

  12. Change in serum iron

    Change in serum iron from baseline to week 24

    Measured: Week 24

  13. Change in ferritin

    Change in ferritin from baseline to week 24

    Measured: Week 24

  14. Change in total iron binding capacity

    Change in total iron binding capacity from baseline to week 24

    Measured: Week 24

  15. Change in hemoglobin

    Change in hemoglobin from baseline to week 24

    Measured: Week 24

  16. All-cause death

    All-cause death

    Measured: Week 24

  17. Hospitalization for heart failure

    Hospitalization for heart failure should include all of the following criteria:

    1. Hospitalization with primary diagnosis of heart failure
    2. Duration of hospitalization of at least 12 hours
    3. New or worsening symptoms of heart failure
    4. Objective evidence of new or worsening heart failure on physical examination or laboratory findings
    5. Initiation or intensification of heart failure treatment.

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2024
  2. Study start1 May 2024 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

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
Model description
A prospective, open label, single center, randomized controlled trial.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
154 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06350487
Sponsor's protocol ID
SMC2024-01-089-003
Acronym
ENRICH-PEF
Status last verified
Apr 2024
First submitted
1 Apr 2024
Last updated
8 Apr 2024
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, de-identified data will be shared upon reasonable request and with permission from the principal investigator.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing SGLT2 inhibitor in people with Heart Failure, Preserved Ejection Fraction, run by Samsung Medical Center 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?

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: status not confirmed, as of the sponsor's last update on 8 Apr 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. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jeong Hoon Yang, MD, PhD (82-2-3410-6475, jhysmc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in peak oxygen consumption (VO2) (time frame: Week 24). 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 NCT06350487.

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 Apr 2024.

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