Heart failure with preserved ejection fraciton
Conditions
Interventions
Empagliflozin 10 mg once daily for 90 days Adjustment of antihypertensive drugs and diuretics 90 days
Adjustment of antihypertensive drugs and diuretics 90 days
Sponsors
Mitsui Memorial Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Age 20 years and older to less than 90 years old 2) Dyspnea on exertion 3) EF 50% on resting echocardiography 4) HFA-PEFF score >= 2 points calculated based on the result of echocardiography at rest 5) peak E/e' (average) >= 15 on exercise stress echocardiography and HFA-PEFF score >= 5 points 6) Patients who have given written informed consent
Exclusion criteria
Exclusion criteria: 1) eGFR< 20 mL/min/1.72m2 2) Already taking SGLT2 inhibitor 3) Type 1 DM 4) A clear cause of dyspnea on exertion other than heart failure 5) At risk of ketoacidosis or hyperosmotic hyperglycemia 6) Pregnant or lactating women 7) Severe regurgitation or moderate or severe stenotic valvular disease. Valve replacement surgery. 8) Regional wall motion disorder of the left ventricle that may cause inaccurate measurement of E/e'. 9) Cardiovascular surgery, implantable cardioverter-defibrillator, implantable cardioverter-defibrillator with biventricular pacing, implantable ventricular assist device, etc. within 30 days 10) Acute coronary syndrome, pulmonary thromboembolism, cerebral infarction, or transient ischemic attack within 90 days 11) Ventricular tachycardia with syncope noted within 90 days. 12) Heart transplantation, implantable artificial heart implantation, or palliative therapy. 13) Patients with severe valvular heart disease who are expected to undergo open heart surgery or catheterization therapy in the near future. 14) Amyloidosis, cardiac sarcoidosis, hemochromatosis, Fabry's disease, or muscular dystrophy. Takotsubo cardiomyopathy, obstructive hypertrophic cardiomyopathy, complicated congenital heart disease, and heart failure due to pericardial contraction 15) Postpartum cardiomyopathy within 6 months 16) Active myocarditis 17) Uncontrolled thyroid disease 18) Symptomatic bradycardia or complete atrioventricular block. Permanent pacemaker implantation. 19) Severe hepatic dysfunction or cirrhosis with portal hypertension 20) Alcohol abuse 21) Active or suspected malignant tumors diagnosed within 2 years. 22) Comorbidities other than heart failure for which prognosis is not expected to be more than 1 year. 23) Participating in a clinical trial with another drug within 30 days 24) Other conditions that may interfere with patient safety or protocol compliance 25) Other patients deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in peak E/e' from baseline to 90 days in exercise stress echocardiography | — |
Secondary
| Measure | Time frame |
|---|---|
| <Secondary outcomes> Changes in peak TR velocity, peak E wave, peak e', and peak DCT in exercise stress echocardiography from baseline to 90 days <Exploratory Endpoint> Changes from baseline to 90 days in resting echocardiography: GLS, atrial strain, LVEF, LVDVI, LVSVI, LVDd, LVDs, LVMI, E/e', TR velocity, E wave, A wave, e', DCT, LA volume, LAD, TAPSE, RVFAC, TRPG, pericardial fat Changes from baseline to 90 days in exercise stress echocardiography: B-line, peak Watt and peak METs Changes in blood tests from baseline to 90 days: NT-proBNP, eGFR, Na, K, Alb, Hgb, Hct, PV, total cholesterol, lymphocytes, Glu, HbA1c Changes in urinalysis from baseline to 90 days: Na, K, Alb, NAG, osmolality | — |
Countries
Japan
Contacts
Public ContactYu Horiuchi
Mitsui Memorial Hospital Division of cardiology
Outcome results
None listed