Patients with heart failure with preserved ejecion fraction (HFpEF) Drug intervention, Empagliflozin, Pressure-Volume Loop
Conditions
Interventions
Empagliflozin (Jadiance10mg)
Intervention
Drug intervention, Empagliflozin
Sponsors
Fukata Mitsuhiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Persons who have given written consent of their own free will 2) Age 40 years or older at the time of obtaining consent, regardless of gender 3) Patients diagnosed with HFpEF (NYHA 1-3) with clinical symptoms of heart failure (fatigue, dyspnea, orthopnea, paroxysmal nocturnal dyspnea, leg edema) plus evidence of left ventricular ejection fraction over 50 percent, elevated left ventricular filling pressure (E/e' >14), and elevated plasma NT-proBNP (> 125 pg/mL).
Exclusion criteria
Exclusion criteria: 1) Patients with a history of cardiomyopathy (dilated cardiomyopathy or hypertrophic cardiomyopathy) 2) Patients with a history of cardiac amyloidosis 3) Patients with a history of cardiac sarcoidosis 4) Patients with early onset of acute myocardial infarction or unstable angina pectoris 5) Patients with constrictive pericarditis 6) Patients with cardiogenic shock 7) Patients with severe hepatic dysfunction (AST > 10 times) 8) Patients with moderate or severe valvular heart disease 9) Patients with uncontrolled arrhythmia (atrial fibrillation, frequent extrasystoles, ventricular tachycardia, ventricular fibrillation) 10) Patients with severe renal dysfunction (eGFR 35 kg/m2 22) Patients with a history of hypersensitivity to SGLT2 inhibitors 23) Pregnant or lactating women 23) Patients who have difficulty administering the research drug through the prescribed route of administration 25) Patients who are unsuitable for cardiac catheterization 26) Patients who are deemed inappropriate for inclusion in the study by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the change in left ventricular diastolic characteristics in the left ventricular end-diastolic pressure-volume relationship using a pressure-volume curve catheter (INCA system) at baseline and 6 months after taking 10 mg of empagliflozin. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will include changes in cardiac characteristics such as end-systolic pressure-volume relationship (ESPVR), Ea, single cardiac output work, potential energy, pressure-volume area (PVA), and energy transfer efficiency by the INCA system. In addition, measures of physical functional capacity will be evaluated, including maximal oxygen uptake, oxygen pulse, cardiac output, blood pressure pulse area, arteriovenous oxygen partial pressure gradient, blood pressure, left ventricular end diastolic volume, global longitudinal strain at rest, and left ventricular ejection fraction. | — |
Contacts
Public ContactMitsuhiro Fukata
Kyushu University Hospital
Outcome results
None listed