Heart failure
Conditions
Interventions
None listed
Sponsors
Hamamatsu University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women aged 45 years or older 2. Patients with no prior treatment with SGLT2 inhibitors 3. Patients with signs and symptoms of heart failure (HF) as determined by the principal investigator
Exclusion criteria
Exclusion criteria: 1. Patients expected to have a life expectancy of less than 3 years due to non-cardiovascular causes 2. Patients currently in a state of decompensated heart failure 3. Patients with valvular disease considered hemodynamically significant by the principal investigator 4. Patients who are candidates for cardiac surgery or catheter intervention 5. Patients with tachycardia exceeding 110 beats per minute at screening 6. Patients with currently life-threatening arrhythmias 7. Patients in whom the principal investigator strongly suspects another primary cause of symptoms (including, but not limited to, the following): ??. Isolated pulmonary arterial hypertension or right-sided heart failure without left-sided heart failure ??. Anemia (hemoglobin < 10 g/dL) ??. Severe chronic obstructive pulmonary disease (COPD) or other pulmonary diseases requiring chronic oxygen therapy, nebulizer use, or oral corticosteroid therapy 8. Patients with an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 (based on the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation) or those undergoing dialysis 9. Patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than three times the upper limit of normal (ULN)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in circulating pathophysiology-related biomarkers | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in circulating inflammatory cytokines Association between genotypes involved in the pharmacological effects of SGLT2 inhibitors and therapeutic response Changes in circulating metabolism-related biomarkers | — |
Countries
Japan
Contacts
Public ContactKoji Suzuki
Hamamatsu University School of Medicine Hospital Pharmacy
Outcome results
None listed