Aortic stenosis Aortic Valve Stenoses
Conditions
Interventions
Patients who meet the eligibility criteria will provide informed consent two days prior to TAVI. They will then be randomized into one of the two groups described below on the day following the TAVI p
Sodium-Glucose Transporter 2 Inhibitors
Sponsors
Kitahara Hideki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient meeting all of the following criteria are eligible for inclusion. 1) A patient with aortic stenosis and the symptomsof heart failure requiring transcatheter aortic valve implantation based on "2020 Guideline on the Management of Valvular Heart Disease". 2) A patient who is scheduled transcatheter aorticvalve implantation at Chiba university hospital. 3) A patient aged between 70 and 90 years at the time of enrollment. 4) A patient with a left ventricular ejection fraction (LVEF) greater than or equal to 40%. 5) A patient who has provided written informed consent to participate in this study (if the patient ca n not sign by oneself, it is acceptable that a family or a person following a family writes on behalf).
Exclusion criteria
Exclusion criteria: 1) Acute heart failure (NYHA class IV) 2) Current use of SGLT-2 inhibitors 3) Allergy, hypersensitivity, or previous intolerance to SGLT-2 inhibitors 4) Chronic cystitis and/or recurrent urinary tract infections occurring more than twice a year 5) Patients with difficulty in oral intake of food 6) Severe renal dysfunction 7) A patient without written informed consent 8) A patient whom the investigator considers to be ineligible as a subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in E/e' (an indicator of left ventricular diastolic dysfunction) at echocardiography examination 168 days (24 weeks) after treatment initiation | — |
Secondary
| Measure | Time frame |
|---|---|
| [Efficacy Secondary Outcomes] Changes in LAVi (Left Atrial Volume Index), LVMi (Left Ventricular Mass Index), SPAP (Systolic Pulmonary Arterial Pressure), TAPSE (Tricuspid Annular Plane Systolic Excursion), S' (Indicator of Right Ventricular Systolic Function), FAC (Fractional Area Change of the Right Ventricle) at 168 days (24 weeks) after treatment initiation NT-proBNP value, change in NT-proBNP at 168 days (24 weeks) follow-up, NYHA functional class at 168 days (24 weeks) follow-up, change in body weight, and incidence of cardiovascular events (cardiovascular death, hospitalization due to heart failure) [Safety Outcomes] Incidence of adverse events (dehydration, acute kidney injury, hypoglycemia, acidosis, urinary tract infection) | — |
Contacts
Public ContactHideki kitahara
Chiba University Hospital
Outcome results
None listed