Chronic heart failure with preserved ejection fraction
Conditions
Interventions
None listed
Sponsors
Hamamatsu University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Men and women => 45 years of age 2. Patients with no prior treatment with SGLT2 inhibitors 3. Signs and symptoms of heart failure (HF) in the judgment of the investigator and a. Stable New York Heart Association (NYHA) II-IV symptoms. b. Ejection fraction (EF) => 40% (stratified maximum 2/3 of patients in either 40-49% or =>50% groups) at the time of HF signs and symptoms or thereafter, less than 24 months prior to enrollment. c. And at least one of the following objective criteria of HF: i. Elevated NT-proBNP or BNP in the last 1 year defined as: Measured as outpatient: NTproBNP => 300 ng/L or BNP => 75 ng/L with sinus rhythm; NTproBNP => 750 ng/L or BNP => 200 ng/L with atrial fibrillation (AF) Measured when hospitalized acutely: NTproBNP => 500 ng/L or BNP => 125 ng/L with sinus rhythm, NT-proBNP => 1250 ng/L or BNP => 350 ng/L with AF. ii. Hospitalization with HF as primary cause in last 12 months and structural heart disease on echocardiography according to ESC guidelines (i.e., either enlarged left atrial volume index (LAVI > 34 ml/m2) or increased left ventricular mass index (LVMI > 95 g/m2 in women and > 115 g/m2 in men). iii. Pulmonary capillary wedge pressure (PCWP) at rest >15 mmHg or > 25 mmHg with exercise. iv. E/e' ratio => 15 at rest on Doppler and tissue Doppler imaging.
Exclusion criteria
Exclusion criteria: Key Exclusion criteria: 1. Life expectancy < 3 years due to non-cardiovascular reasons. 2. Current decompensated HF. 3. Primary cardiomyopathy (e.g., constrictive, restrictive, infiltrative, toxic, hypertrophic (genetic), congenital, or any primary cardiomyopathy in judgment of investigator). 4. Current hemodynamically significant valve disease in opinion of investigator. 5. Any condition with indication for cardiac surgery or catheter intervention. 6. EF ever documented < 40%. 7. Any event (e.g., acute myocardial infarction) that may have reduced EF, that occurred after the echocardiogram used for inclusion, unless repeat echocardiogram confirms EF => 40%. 8. Tachycardia > 110 beats/min at screening. 9. Any current life-threatening dysrhythmia. 10. Probable alternative primary reason for patient's symptoms in judgment of investigator, including but not limited to: a. Isolated pulmonary arterial hypertension or right ventricular (RV) failure; in the absence of left-sided HF. b. Anemia (hemoglobin < 10 g/dl). c. Severe chronic obstructive pulmonary disease (COPD) or lung disease (chronic oxygen use, nebulizer use, or oral steroid therapy). 11. Estimated glomerular filtration rate < 30 ml/min/1.73m2 (based on the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation), or on dialysis. 12. Alanine transaminase (ALT) or aspartate aminotransferase (AST) => 3x upper limit of normal (ULN). Resampling is not allowed during the same screening period if detected abnormal values do not have reasonable explanation and are not expected to return to normal level within few days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hospitalization for worsening heart failure (including unscheduled visits or intravenous diuretic use in the emergency setting) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in NT-proBNP from baseline 2) Changes in inflammation-related proteome 3) Changes in serum metabolome 4) Incidence of adverse events | — |
Countries
Japan
Contacts
Public ContactKoji Suzuki
Hamamatsu University School of Medicine Hospital Pharmacy
Outcome results
None listed