Risk Factors In Heart Failure Patients With Preserved Ejection Fraction

NCT ID: NCT06487468

Last Updated: 2024-07-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 9419 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-05-01
• Study Completion Date: 2024-01-31

Brief Summary

This study aimed to identify the independent risk factors associated with heart failure readmission, cardiac mortality and all-cause death among patients discharged from Xiangtan Central Hospital with heart failure and preserved ejection fraction (HFpEF). Understanding related risk factors might add future clinical decision making for individualized post discharge management of HFpEF patients aiming to improve the outcome of discharged HFpEF patients.

Detailed Description

This study sought to determine the independent risk factors linked to endpoint events (which include all-cause mortality or readmission for heart failure, cardiovascular death) among hospitalized patients with heart failure and preserved ejection fraction (HFpEF) at Xiangtan Central Hospital during the period from May 1, 2014, to January 31, 2023. The clinical follow up ended on January 31, 2024. The study examined the risk factors associated with the endpoint outcome (cardiovascular death and death from any cause and readmission due to heart failure) to provide clinical evidence for intervening discharged HFpEF patients, with the objective of improving patient outcomes in future clinical practice.

The clinical features of hospitalized heart failure with preserved ejection fraction (HFpEF, EF≥50%) are analyzed retrospectively by reviewing the patient's demographic, clinical data, including patient medical history, initial clinical evaluations, and therapeutic interventions, as well as echocardiographic data in the hospital's electronic health records and relevant databases. The clinical outcome of enrolled patients are obtained through a team of three experienced cardiologists and twelve nursing professionals through outpatient consultations, telephone follow-ups, and community visit. The primary endpoint events are all-cause mortality, the second endpoints are the composite cardiovascular death and heart failure readmission.

Conditions

Heart Failure With Preserved Ejection Fraction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

HFpEF Group

HFpEF (Heart failure with preserved ejection fraction): LVEF≥50%.

Non-endpoint events group versus Endpoint events (all-cause death,cardiovascular death or heart failure readmission) group

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients discharged with diagnosis of heart failure were screened and met definition of heart failure with preserved ejection fraction (HFpEF) according to the 2021 European Society of Cardiology (ESC) guidelines at final analysis.
• 1）Heart failure signs and symptoms; 2）LVEF>50%;

Exclusion Criteria

• 1) age under 18 years; 2) life expectancy of less than one year due to non-cardiac conditions.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiangtan Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jianping Zeng

Director of Cardiovascular Department of Xiangtan Central Hospital,Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Zhu Y, Zhao W, Liu Z, Tan D, Tao L, He W, Jiang K, Huang H, Wu M, Tang L, Zeng J, Zhou S. Development and validation of a prediction model for all-cause death in heart failure patients with preserved ejection fraction: a single-centre cohort study in China. BMJ Open. 2025 Sep 10;15(9):e094909. doi: 10.1136/bmjopen-2024-094909.

Reference Type: DERIVED

PMID: 40935414 (View on PubMed)

Other Identifiers

2024/6

Identifier Type: -

Identifier Source: org_study_id