None listed
Conditions
Interventions
Drug : A total of 154 patients with HFpEF will be enrolled at Samsung Medical Center in South Korea. Stable/chronic ambulatory patients without hospitalization within the last 30 days due to heart fai
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [Inclusion Criteria] (1) 19 years of age or older (2) NYHA Class II-? Dyspnea (3) HFpEF diagnosis (irrespective of time from diagnosis)3 ? Noninvasive i. LVEF =50% ii. NT-proBNP =220 pg/mL or BNP =80 pg/mL if in sinus rhythm NT-proBNP =660 pg/mL or BNP =240 pg/mL if in atrial fibrillation (AF) iii. Echocardiography with at least one of the following criteria: - LAVI =34 ml/m2 if AF - Lateral E/e' =9 - LVMI (left ventricular mass index) =115 g/m2 if male or =95 g/m2 if female - LV (left ventricular) wall thickness =12mm ? Invasive: LVEDP =16 mmHg or PCWP =15mmHg (4) Stable/chronic ambulatory patients without hospitalization within the last 30 days due to heart failure decompensation episode (5) If a heart failure-related drug is being administered, a person is being administered stably without changing the dose for at least 3 weeks prior to randomization
Exclusion criteria
Exclusion criteria: [Exclusion Criteria] (1) The procedures described in this protocol are not desired or impossible (2) If walking ability is limited due to joint disease, other motor dysfunction, or lung disease other than cardiopulmonary fitness (3) New York Heart Association (NYHA) Class IV Person (4) Type 1 diabetes (5) eGFR <60 ml/min/1.73m2 (according to CKD-EPI formula) (6) (6) Hb<7g/dL (7) Severe liver damage (Child-Pugh class C) (8) Acute myocardial infarction (Acute MI), Unstable angina (Unstable angina) within 30 days of study selection, or coronal revascularization scheduled for study selection (9) Serious left heart valve disease (moderate to severe stenosis and severe regurgitation) (10) Heart failure due to any of the following: invasive cardiomyopathy (amyloidosis, sarcoidosis), active myocarditis (active myocarditis), constrictive pericarditis, hypertrophic cardiomyopathy (11) Low blood pressure with symptoms (systolic blood pressure <90mmHg) (12) Severe chronic obstructive pulmonary disease (postbronchodilator FEV1/FVC <70% and FEV1 <50%) (13) If treated with SGLT2 inhibitor within 30 days of selection of study subject (14) If you have a history of diabetic ketoacidosis during treatment with SGLT2 inhibitors (15) Current history or history of recurrent urinary tract and genital infection (16) Patients with a history of hypersensitivity reactions to SGLT2 inhibitors (17) If the survival period is within two years due to a comorbid condition other than heart disease, or if it is deemed difficult to comply with the protocol due to alcohol or substance abuse, etc., (according to medical judgment of the field investigator) (18) Female patients who are currently pregnant or plan to become pregnant (19) Female patients who are breastfeeding or plan to breastfeed (20) Participating in other clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in maximum oxygen consumption at 24 weeks compared to baseline (24 weeks - baseline) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in minute ventilation to carbon dioxide output ratio (VE/VCO2 slope) ;Change in conventional echo parameters (LAVI, Lateral E/e', LVMI, LV wall thickness) before and after maximal exercise ;Change in LV global longitudinal strain, LA (left atrial) strain, RV (right ventricular) free wall strain before and after maximal exercise ;Change in health-related quality of life assessed by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS) ;Change in NT-proBNP level ;Change in chronotropic response reserve assessed by change in heart rate from rest to peak exercise ;Change in serum iron, ferritin, total iron binding capacity, and hemoglobin ;Hospitalization due to death, heart failure | — |
Countries
Korea, Republic of
Contacts
Public ContactJeong Hoon Yang
Samsung Medical Center
Outcome results
None listed