NCT05240118

Brief Summary

This study aimed to define the independent risk factors related cardiac events (cardiac death or heart failure-related hospitalization) among heart failure with mildly reduced ejection fraction (HFmrEF) patients who discharged from the Xiangtan Central Hospital. Through the long-term follow-up the cardiovascular outcome of patients being discharged from the hospital, the risk factors related to cardiovascular outcome (cardiac death or heart failure-related hospitalization) will be explored to provide clinical evidence to intervene the discharged HFmrEF patients aiming to improve patients outcome in the future clinical practice.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,693

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

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

January 1, 2015

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 15, 2022

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

5.7 years

First QC Date

December 3, 2021

Last Update Submit

February 10, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Long-term risk factors related to cardiac events (cardiac death or heart failure-related rehospitalization) in discharged patients with heart failure with mildly reduced ejection fraction

    Primary Outcome Measure: 1.Long-term risk factors related to cardiac events (cardiac death or heart failure-related rehospitalization) in discharged patients with heart failure with mildly reduced ejection fraction The clinical features of hospitalized heart failure with mildly reduced ejection fraction (HFmrEF, EF 41-49%) will be analyzed retrospectively by reviewing their medical records, laboratory and clinical imaging examination results during initial hospitalization, clinical outcome up to the study end will be obtained through clinical visit and telephone call.

    The last patients would be clinically followed-up until August 31, 2021 per clinical visit or telephone call.

Secondary Outcomes (1)

  • Long-term risk factors related to all-cause death in discharged patients with heart failure with mildly reduced ejection fraction

    The last patients would be clinically followed-up until August 31, 2021 per clinical visit or telephone call

Study Arms (1)

HFmrEF Group

HFmrEF (Heart failure with mildly reduced ejection fraction): ESC Guideline heart failure 2021: patients with LVEF 41-49%. non-cardiac events group versus cardiac events (cardiac death or heart failure-related rehospitalization) group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who attended the Xiangtan Cengtral Hospital in the time period between January 1, 2015 and August 31, 2020 with the diagnosis of HFmrEF.

You may qualify if:

  • Diagnosis: Heart failure with mildly reduced ejection fraction (HFmrEF) Presence of symptoms and/or signs of HF, and a mildly reduced LVEF (41- 49%); Elevated natriuretic peptides (BNP \>35 pg/mL or NT-proBNP \>125 pg/mL); Other evidence of structural heart disease.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Liu Z, Zhu Y, Chen S, Wu M, Huang H, Peng K, Zhang L, Zhao W, Peng X, Li N, Zhang H, Zhou Y, Peng Y, Fan J, Zeng J. Sex differences in patients with heart failure and mildly reduced left ventricular ejection fraction. Sci Rep. 2023 Apr 26;13(1):6832. doi: 10.1038/s41598-023-33733-8.

Study Officials

  • Jianping Zeng, M.D.

    Xiangtan Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 3, 2021

First Posted

February 15, 2022

Study Start

January 1, 2015

Primary Completion

August 31, 2020

Study Completion

August 31, 2021

Last Updated

February 15, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share