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

Not Applicable

• Conditions: Patients with heart failure with preserved ejecion fraction (HFpEF); Drug intervention, Empagliflozin, Pressure-Volume Loop; HFpEF/I509

• Registration Number: JPRN-jRCTs071230020
• Lead Sponsor: Hieda Michinari

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 38

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified