The Impact of Empagliflozin on Left Ventricular Myocardial Stiffness in Heart Failure with Preserved Ejection Fraction

JRCT ID: jRCTs071230020

Registered date:12/06/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Patients with heart failure with preserved ejecion fraction (HFpEF)
• Date of first enrollment: 12/06/2023
• Target sample size: 38
• Study type: Interventional
• Intervention(s): Empagliflozin (Jadiance10mg)

Outcome(s)

• Primary Outcome: 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 Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include 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).

Exclude 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 < 30 ml/min/1.73 m2) and patients on dialysis
11) Patients with a history of type 1 diabetes mellitus (including a history of ketoasdosis and diabetic foot)
12) Patients with a history of ketoacidosis
13) Patients with a history of diabetic foot
14) Patients with a history of coagulation abnormalities
15) Patients with symptomatic hypotension (systolic blood pressure <100 mmHg prior to randomization)
16) Patients with a history of peripheral arterial disease
17) Patients with pulmonary diseases such as COPD and interstitial pneumonia
18) Patients with active infectious diseases
19) Patients with a life expectancy of less than 1 year due to malignancy
20) Patients who cannot walk or cycle
21) Obese patients with BMI > 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

Related Information

• Primary Sponsor: Hieda Michinari
• Source(s) of Monetary Support: Nippon Boehringer Ingelheim Co. Ltd.