heart failure with preserved ejection fraction
Conditions
Interventions
Empagliflozin intervention group:Standard treatment+empagliflozin
Observation group:Standard treatment
Sponsors
The Third Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18 to 75 years, gender is not limited; (2) Patients with chronic HF (NYHA grade II and III) diagnosed for at least 3 months,with LVEF =40% of the last assessed before enrollment,and Elevated N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) >300 pg/mL (3) Creatinine clearance (GFR) =30ml/min/1.73m^2; (4) Be able to understand and voluntarily sign the informed consent form; (5) Good compliance;
Exclusion criteria
Exclusion criteria: (1) diabetics; (2) Acute coronary syndrome in the past 2 months, or coronary revascularization planned during the trial; (3) Atrial fibrillation, cardiovascular and cerebrovascular events related to atrial fibrillation in the last three months; (4) Patients with severe hepatic insufficiency; (5) Patients who have taken SGLT2i within 4 weeks before enrollment; (6) There are serious arthropathy, peripheral vascular disease, pulmonary hypertension, chronic obstructive pulmonary disease and other diseases that affect the results of cardiopulmonary exercise test; (7) The subject's resting ECG has the following abnormalities: (1) ventricular explicit pre-excitation syndrome; (2) ventricular pacing rhythm; (3) The resting ST segment is depressed by more than 2mm; (4) left bundle branch block or any intraventricular conduction difference and QRS time of more than 120ms; (8) Congenital heart defects, progressive decompensated congestive heart failure, severe valvular disease, hypertrophic obstructive cardiomyopathy, severe uncontrolled hypertension (sitting systolic blood pressure >180mmHg or diastolic blood pressure >110mmHg), severe anemia, suspected or known arterial dissection, acute myocarditis or pericarditis, active endocarditis, thrombophlebitis, or pulmonary embolism. (9) History of bleeding tendency, cerebral hemorrhage, or epilepsy requiring anticonvulsant medication. (10) Pregnancy or breastfeeding. (11) Participate in any other clinical trial within 30 days of the first visit, or take any investigational drug. (12) Drug abuse. The patient has a history of alcohol abuse or known drug dependence in the past 2 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VO2 peak;O2 pulsepeak;anaerobic threshold;VE/VCO2; | — |
Secondary
| Measure | Time frame |
|---|---|
| LVEF;LVEDV;LAV;E/E’;Pulmonary artery pressure;NYHA cardiac function grading;Minnesota Heart Failure Quality of Life Questionnaire;Glomerular filtration rate;N terminal pro B type natriuretic peptide;Alanine aminotransferase;Aspartate aminotransferase; | — |
Countries
China
Contacts
Public ContactZhaoqi Huang
The Third Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed