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Clinical Study of Active Intervention in High-risk HFpEF Patients
Sponsor: Xiangtan Central Hospital
Summary
Based on inclusion and exclusion criteria, this experiment plans to include 924 Heart Failure with Preserved Ejection Fraction(HFpEF) patients with increased risk of all-cause death. The enrolled patients will divided into usual care group (n=462) and targeted intervention group (n=462) in a 1:1 ratio. The usual care patients will receive routine heart failure treatment. Patients in targeted intervention group, on top of routine therapy for heart failure, will receive further therapy targeting therapy to correct hypoalbuminemia, anemia or hyponatremia, and try to enhance medication to lower N-terminal pro brain natriuretic peptide (NT-proBNP), C-reactive protein(CRP), New York Heart Association(NYHA )Classification, to add diuretics for patients with higher right ventricular diameters(RADs),multidiscipline intervention for patients complicating chronic obstructive pulmonary disease(COPD), and actively reperfusion for ischemic HFpEF patients. The incidence of all-cause death will be compared after 3 years follow-up.The primary endpoint is the occurrence of all-cause mortality events during the follow-up period.
Official title: Randomized Multicenter Clinical Trial in Heart Failure Patients With Preserved Ejection Fraction (HFpEF) at Intermediate and High Risk of All-cause Death
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
924
Start Date
2024-08-01
Completion Date
2028-08-01
Last Updated
2024-08-01
Healthy Volunteers
No
Interventions
Targeted intervention based on risk factors
Correct hypoalbuminemia, anemia or hyponatremia, and try to enhance medication to lower NT-proBNP, CRP, NYHA Classification, to add diuretics for patients with higher RADs, multidiscipline intervention for patients complicating COPD, and actively reperfusion for ischemic HFpEF patients.