Outcome of Discharged HFmrEF Patients (OUDI-HF)

February 10, 2022 updated by: Jianping Zeng, Xiangtan Central Hospital

Risk Factors of Short-term and Long-term OUtcome in DIscharged Patients With Heart Failure With Mildly Reduced Ejection Fraction

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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 hospitalized in Xiangtan Central Hospital from January 1, 2015 to August 31, 2020. The patients would be clinically followed-up until August 31, 2021 per clinical visit or telephone call, 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.

The clinical features of hospitalized heart failure with mildly reduced ejection fraction (HFmrEF, EF 41-49%) will be analyzed by retrospectively by reviewing patients medical records, laboratory and clinical imaging examination results during initial hospitalization, clinical outcome of enrolled patients will be obtained through clinical visit and telephone call. The primary endpoint is the composite cardiac events (cardiac death or heart failure related rehospitalization). The secondary endpoint is the all-cause death.

Study Type

Observational

Enrollment (Actual)

1693

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: The last patients would be clinically followed-up until August 31, 2021 per clinical visit or telephone call.

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term risk factors related to all-cause death in discharged patients with heart failure with mildly reduced ejection fraction
Time Frame: The last patients would be clinically followed-up until August 31, 2021 per clinical visit or telephone call
1. Long-term risk factors related to all-cause death 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, all-cause death 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiangtan Central Hospital

Investigators

  • Principal Investigator: Jianping Zeng, M.D., Xiangtan Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

August 31, 2020

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

December 3, 2021

First Submitted That Met QC Criteria

February 10, 2022

First Posted (Actual)

February 15, 2022

Study Record Updates

Last Update Posted (Actual)

February 15, 2022

Last Update Submitted That Met QC Criteria

February 10, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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