Effect of Bilirubin on Prognosis in Heart Failure With Preserved Ejection Fraction

April 22, 2024 updated by: Dongying Zhang, Chongqing Medical University
Factors influencing the prognosis of patients with heart failure with preserved ejection fraction (HFpEF) have been extensively studied. Previous studies have found that elevated serum total bilirubin levels are associated with cardiac death, heart failure readmission, and all-cause mortality in patients with chronic heart failure. However, the relationship between direct bilirubin and prognosis in patients with HFpEF is unclear.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Patients with heart failure with preserved ejection fraction account for approximately 50% of all heart failure patients, have approximately 1.4 hospitalisations per year and an annual mortality rate of approximately 15%. Till now, there have no definitively proven therapies that can reduce their morbidity and mortality, HFpEF Patients have a poor prognosis. The current study found that the prognosis of patients with HFpEF may be related to the heterogeneity of the disease, its various phenotypes and multifactorial pathophysiology, which has not been fully elucidated. The current study found that bilirubin is a risk factor for adverse outcomes of various HFpEF-related complications, but the relationship between direct bilirubin and prognosis of HFpEF has not been reported. Therefore the investigators speculate that direct bilirubin is a predictor of prognosis of HFpEF patients.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dongying Zhang, doctor
  • Phone Number: +8613608398395
  • Email: zdy.chris@qq.com

Study Locations

  • China
      • Chongqing, China
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

heart failure with preserved ejection fraction (HFpEF)

Description

Inclusion Criteria:

  • Adult aged ≥18 years old；
  • Diagnosed with HFpEF.

Diagnostic criteria including:

  1. left ventricular ejection fraction ≥ 50%;
  2. with the symptoms and/or signs of heart failure;
  3. Patients in sinus rhythm：BNP≥35pg/ml and/or NT-proBNP≥125pg/ml；Patients with atrial fibrillation：BNP≥105pg/ml and/or NT-proBNP≥365pg/ml.

Exclusion Criteria:

  • LVEF less than 49% at any time

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

Cohorts and Interventions

Group / Cohort
DB≤6.8µmol/L
heart failure with preserved ejection fraction patients with direct bilirubn ≤6.8µmol/L
DB>6.8µmol/L
heart failure with preserved ejection fraction patients with direct bilirubn >6.8µmol/L

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The level of direct bilirubin
Time Frame: The day when patients on admission
The level of direct bilirubin
The day when patients on admission
a composite of heart failure rehospitalization or all-cause mortality
Time Frame: In an average of 3 year after discharge
a composite of heart failure rehospitalization or all-cause mortality
In an average of 3 year after discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
heart failure rehospitalization
Time Frame: In an average of 3 year after discharge
heart failure rehospitalization
In an average of 3 year after discharge
all-cause mortality
Time Frame: In an average of 3 year after discharge
all-cause mortality
In an average of 3 year after discharge

Collaborators and Investigators

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

Sponsor

Chongqing Medical University

Investigators

  • Study Director: Dongying Zhang, doctor, First Affiliated Hospital of Chongqing Medical University

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)

September 20, 2020

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

April 15, 2024

First Submitted That Met QC Criteria

April 22, 2024

First Posted (Actual)

April 23, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-04-16

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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