Heart Failure with Preserved Ejection Fraction
Conditions
Interventions
Experimental group:Standard treatment for heart failure + Sacubatril valsartan
Control group:Standard treatment for heart failure + Valsartan
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Obtain written informed consent before starting the evaluation; 2. Aged >=18 years; 3. Meet the HFpEF diagnostic criteria in the "2018 Chinese Guidelines for the Diagnosis and Treatment of Heart Failure": 1) Symptoms of heart failure at visit 1 (NYHA grade II-IV). 2) BNP > 35ng/L or NT-proBNP > 125ng/L during screening. 3) Echocardiographic examination within 6 months before screening showed that LVEF >= 50%. 4) Ventricular hypertrophy (the thickness of the ventricular septum or the thickness of the left ventricular posterior wall >= 11mm) and/or left atrium enlargement (the transverse diameter of the left atrium >= 38mm or the long diameter of the left atrium >=50mm or the area of the left atrium >= 20m2 or the volume of the left atrium >= 55mL or Left atrial volume index >= 29mL/m2) and/or abnormal diastolic function (ventricular septum e'=15 or tricuspid valve displacement velocity > 2.8 m/s). 4. Body mass index (BMI) >= 25kg/m2.
Exclusion criteria
Exclusion criteria: 1. Any previous echocardiographic measurement of LVEF 5.2mmol/L. 7. Symptomatic hypotension or SBP < 90 mmHg. 8. Severe liver function abnormality (ALT or AST exceeding 3 times the upper limit of normal). 9. Acute coronary syndrome, acute stroke, coronary stent or coronary artery bypass graft, other major cardiovascular surgery within 1 month. 10. Severe arrhythmia has not been controlled. 11. Other non-cardiogenic diseases that cause breathing difficulties, such as acute and chronic respiratory dysfunction. 12. There are other serious organ diseases, and the investigator judges them to be unsuitable for enrollment. 13. Pregnant women or women who are planning to give birth.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite endpoint of cardiovascular death, readmission due to heart failure, or emergency medical visit due to heart failure; | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality;Readmission due to heart failure, or emergency medical visit due to heart failure;Cardiovascular death;NT-proBNP level;Quality of life improvement (changes in KCCQ score);NYHA class;E/e' value; | — |
Countries
China
Contacts
Public ContactZhou Jingmin
Zhongshan Hospital, Fudan University
Outcome results
None listed