Heart failure with preserved ejection fraction
Conditions
Interventions
Sponsors
Beijing Fengtai Hospital
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Able to provide written informed consent. 2. Age >=40 years; 3. Stable heart failure (with or without type 2 diabetes mellitus); 4. LVEF >50% (recorded within 12 months prior to enrollment via echocardiography or cardiac magnetic resonance imaging, with no subsequent events that may reduce LVEF), and evidence of structural heart disease within 12 months (defined as: left atrial (LA) enlargement meeting any of the following criteria: LA width (diameter) >=3.8 cm, or LA length >=5.0 cm), left ventricular hypertrophy with interventricular septal or posterior wall thickness >=1.1 cm. 5. Natriuretic peptide (BNP) =100 pg/mL.
Exclusion criteria
Exclusion criteria: 1. Receiving SGLT2 inhibitor treatment within 4 weeks prior to randomization or previous intolerance to SGLT2 inhibitors. 2. Type 1 diabetes mellitus. 3. Glomerular filtration rate (eGFR) =160 mmHg if not on >=3 antihypertensive medications, or >=180 mmHg if on treatment. Measurements must be taken twice consecutively with a 5-minute interval. 6. Myocardial infarction, unstable angina, coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting), atrial flutter/fibrillation ablation, or valve repair/replacement, with no such treatments within 12 weeks prior to enrollment. Patients must undergo standardized echocardiography and/or cardiac MRI at least 12 weeks after the event. 7. Planned coronary revascularization, atrial flutter/fibrillation ablation, or valve repair/replacement. 8. Stroke or transient ischemic attack within 12 weeks prior to enrollment. 9. Other or concomitant diagnoses that may explain the patient's heart failure symptoms and signs (e.g., anemia, hypothyroidism), as determined by the investigator. 10. Body mass index >50 kg/m^2. 11. Any of the following within 12 months prior to enrollment: primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease (including chronic obstructive pulmonary disease requiring continuous home oxygen, long-term nebulizer therapy, oral steroids, or ventilator support due to exacerbation). 12. Prior heart transplantation or complex congenital heart disease. Planned cardiac resynchronization therapy. 13. Heart failure caused by any of the following: known infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis, lymphoma, intramyocardial fibrosis), active myocarditis, constrictive pericarditis, pericardial tamponade, known hereditary hypertrophic cardiomyopathy or obstructive hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy/dysplasia, or uncorrected primary valvular disease. 14. Life expectancy <2 years due to non-cardiovascular conditions, as judged by the investigator. 15. Active malignancy requiring treatment (excluding basal cell or squamous cell skin cancer). 16. Acute or chronic liver disease with severe impairment (e.g., ascites, esophageal varices, coagulopathy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BNP;Global longitudinal strain, GLS; | — |
Countries
China
Contacts
Public ContactWen Jing
Beijing Fengtai Hospital
Outcome results
None listed