NCT06487468

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,419

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2014

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 5, 2024

Completed
Last Updated

July 8, 2024

Status Verified

July 1, 2024

Enrollment Period

8.8 years

First QC Date

June 27, 2024

Last Update Submit

July 3, 2024

Conditions

Keywords

HFpEF, Outcome

Outcome Measures

Primary Outcomes (1)

  • All-cause death(people)

    Risk factors of all-cause death are analyzed(Increase the factors that contribute to the occurrence of endpoint events)

    The patients are clinically followed up until January 31, 2024, per clinical visit or telephone call or community visit.

Secondary Outcomes (1)

  • Cardiovascular death and Heart failure readmission(people)

    The patients are clinically followed up until January 31, 2024, per clinical visit or telephone call or community visit.

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who hospitalized the Xiangtan Central Hospital between May 1, 2014, and January 31, 2023, with the diagnosis of heart failure and met HFpEF criteria at final analysis.

You may qualify if:

  • 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.
  • )Heart failure signs and symptoms; 2)LVEF\>50%;

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Cardiovascular Department of Xiangtan Central Hospital,Clinical Professor

Study Record Dates

First Submitted

June 27, 2024

First Posted

July 5, 2024

Study Start

May 1, 2014

Primary Completion

January 31, 2023

Study Completion

January 31, 2024

Last Updated

July 8, 2024

Record last verified: 2024-07