The Efficacy of Enavogliflozin in Heart Failure With Preserved Ejection Fraction

NCT06350487 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: SMC2024-01-089-003
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Heart Failure, Preserved Ejection Fraction

Keywords

Heart failure with preserved ejection fraction; Sodium glucose cotransporter 2 inhibitors; Exercise performance

Outcome Measures

Primary Outcomes (1)

• Change in peak oxygen consumption (VO2)

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

  Week 24

Secondary Outcomes (17)

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

  Week 24

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

  Week 24

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

  Week 24

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

  Week 24

• Change in LV wall thickness before and after maximal exercise

  Week 24

Study Arms (2)

SGLT2 inhibitor group

EXPERIMENTAL

SGLT2 inhibitor group will receive Enavogliflozin (0.3mg oral tablet once daily).

Drug: SGLT2 inhibitor

Control group

NO INTERVENTION

Control group will not receive any SGLT2 inhibitors during the study period.

Interventions

SGLT2 inhibitor DRUG

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

Also known as: SGLT2 inhibitor: Enavogliflozin (Brand names: Envlo tab)

SGLT2 inhibitor group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Age ≥19 2) New York Heart Association (NYHA) II-III dyspnea 3) Diagnosis of HFpEF (Exams conducted within 6 months from screening) \[must satisfy all (1), (2), and (3)\]
• Left ventricular ejection fraction (LVEF) ≥50%
• 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
• 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

You may not qualify if:

• Unwillingness or inability to comply with the procedures described in this protocol
• 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
• NYHA IV dyspnea
• Type 1 diabetes mellitus
• Estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73m2 (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula)
• Anemia (Hb \<7g/dL)
• Severe hepatic impairment (Child-Pugh class C)
• Significant left-sided valvular heart disease (moderate to severe stenosis and severe regurgitation)
• Heart failure due to any of the following: infiltrative cardiomyopathy (amyloidosis, sarcoidosis), active myocarditis, constrictive pericarditis, hypertrophic cardiomyopathy
• Symptomatic hypotension (systolic blood pressure \<90mmHg)
• Severe chronic obstructive pulmonary disease (postbronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity(FVC) \<70% and FEV1 \<50%)
• History of diabetic ketoacidosis while in treatment with SGLT2i
• Recurrent genitourinary tract infections
• History of Hypersensitivity reaction to SGLT2i
• 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)

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Heart Failure, Diastolic

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Officials

• Jeong Hoon Yang, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeong Hoon Yang, MD, PhD

CONTACT

82-2-3410-6475; jhysmc@gmail.com

David Hong, MD

CONTACT

82-2-3410-6475; hongdawi@naver.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical outcome assessment will be performed under blinded assessment about the allocated treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A prospective, open label, single center, randomized controlled trial.

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 5, 2024
• Study Start: May 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After publication of first manuscript and trial results, de-identified data will be shared upon reasonable request and with permission from the principal investigator.
• Access Criteria: After publication of first manuscript and trial results, de-identified data will be shared upon reasonable request and with permission from the principal investigator.

Locations

KR (1)