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Clinical Trials/NCT06532019
NCT06532019
Not yet recruiting
Not Applicable

Randomized Multicenter Clinical Trial in Heart Failure Patients With Preserved Ejection Fraction (HFpEF) at Intermediate and High Risk of All-cause Death

Xiangtan Central Hospital0 sites924 target enrollmentAugust 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure With Preserved Ejection Fraction
Sponsor
Xiangtan Central Hospital
Enrollment
924
Primary Endpoint
all-cause mortality
Status
Not yet recruiting
Last Updated
last year

Overview

Brief 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.

Detailed Description

Our newly finished study developed and validated a risk prediction model for all-cause mortality in patients with HFpEF based on real-world data. The nomogram prediction model included factors such as NT-proBNP, albumin, age, NYHA class III-IV, CRP, RADs, hemoglobin, COPD, hyponatremia, and Percutaneous Coronary Intervention(PCI). Discharged HFpEF patients with scores ≥200.37 were found to be associated with increased risk of all-cause death up to 3 years. In this trial, we sought to evaluate the impact of targeted risk factors intervention post-discharge in patients with with scores ≥200.37 on all-cause death up to 3 years. Based on inclusion and exclusion criteria,We will enroll 924 patients with HFpEF and scores ≥200.37. The enrolled patients will divided into a usual care group (n=462) and targeted intervention group (n=462) in a 1:1 ratio. The usual care group 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 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. The primary endpoint is the occurrence of all-cause mortality events during the 3 years follow-up period.

Registry
clinicaltrials.gov
Start Date
August 1, 2024
End Date
August 1, 2028
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jianping Zeng

Dean, Xiangtan Central Hospital ,Director of cardiovascular clinic, Clinical Professor

Xiangtan Central Hospital

Eligibility Criteria

Inclusion Criteria

  • Discharged HFpEF patients with risk score \> or equal 200.37.

Exclusion Criteria

  • Patients with a life expectancy of less than 1-year due to malignancy.

Outcomes

Primary Outcomes

all-cause mortality

Time Frame: The patients will be followed up for 3 years after they were enrolled.

follow-up by clinical visit, telephone call or community visit

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