The Efficacy of Enavogliflozin in Heart Failure With Preserved Ejection Fraction

Last updated: April 5, 2024
Sponsor: Samsung Medical Center
Overall Status: Active - Not Recruiting

Phase

4

Condition

Congestive Heart Failure

Chest Pain

Heart Failure

Treatment

SGLT2 inhibitor

Clinical Study ID

NCT06350487
SMC2024-01-089-003
  • Ages > 19
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

  1. Inclusion Criteria:
  1. Age ≥19 2) New York Heart Association (NYHA) II-III dyspnea 3) Diagnosis of HFpEF (Examsconducted within 6 months from screening) [must satisfy all (1), (2), and (3)]
  1. Left ventricular ejection fraction (LVEF) ≥50%
  2. 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
  3. Satisfying either noninvasive or invasive criteria I. Noninvasive: Echocardiographywith 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 wedgepressure(PCWP) ≥15mmHg 4) Stable/chronic ambulatory patients withouthospitalization within the last 30 days due to heart failure decompensationepisode 5) Patients taking heart failure medication without change for at least 3weeks before screening

Exclusion

  1. Exclusion Criteria:
  2. Unwillingness or inability to comply with the procedures described in thisprotocol
  3. The ability to walk is, in the investigator's opinion, clearly limited byjoint disease or other locomotor problems or lung diseases rather than bycardiorespiratory fitness
  4. NYHA IV dyspnea
  5. Type 1 diabetes mellitus
  6. Estimated glomerular filtration rate (eGFR) <60 ml/min/1.73m2 (ChronicKidney 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 beforeinclusion or planned coronary revascularization at the time of inclusion
  10. Significant left-sided valvular heart disease (moderate to severe stenosisand 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 forcedexpiratory volume in 1 second (FEV1)/forced vital capacity(FVC) <70% andFEV1 <50%)
  14. Treated with sodium-glucose cotransporter-2 inhibitors (SGLT2i) within 30days 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 orthat may result in protocol non-compliance (per site investigator's medicaljudgment)
  19. Female patients who are currently or planning to become pregnant
  20. Female patients who are lactating
  21. Patients participating in other clinical trials

Study Design

Total Participants: 154
Treatment Group(s): 1
Primary Treatment: SGLT2 inhibitor
Phase: 4
Study Start date:
May 01, 2024
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Site Not Available

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