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RecruitingNCT06379152Updated Apr 23, 2024

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

An observational study in Heart Failure With Preserved Ejection Fraction and Prognathism, sponsored by Chongqing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-23.

Sponsored by Chongqing Medical University · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as recruiting.
  • Started Sep 2020; still recruiting 6 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Heart Failure With Preserved Ejection Fraction
  • Prognathism

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Keywords

  • Heart Failure with Preserved Ejection Fraction
  • Bilirubin
  • Prognosis
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In context

Prognathism

11 studies on the registry are indexed under Prognathism; 6 are open to participants now.

Browse Prognathism studies →

Lead sponsor

Chongqing Medical University is the lead sponsor of 78 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

heart failure with preserved ejection fraction (HFpEF)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Diagnostic criteria including:

  1. ≥ 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

Exclusion Criteria:

  • less than 49% at any time
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. The level of direct bilirubin

    The level of direct bilirubin

    Time frame: The day when patients on admission

  2. a composite of heart failure rehospitalization or all-cause mortality

    a composite of heart failure rehospitalization or all-cause mortality

    Time frame: In an average of 3 year after discharge

Secondary outcomes

  1. heart failure rehospitalization

    heart failure rehospitalization

    Time frame: In an average of 3 year after discharge

  2. all-cause mortality

    all-cause mortality

    Time frame: In an average of 3 year after discharge

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06379152
Lead sponsor
Chongqing Medical University
Responsible party
Dongying Zhang (Clinical Professor, Chongqing Medical University) — Principal investigator
First posted
Apr 23, 2024
Start date
Sep 20, 2020
Primary completion
Jun 30, 2024 (estimated)
Completion
Jul 1, 2024 (estimated)
Last update
Apr 23, 2024

Study contacts

Dongying Zhang, doctor
Contact
zdy.chris@qq.com
+8613608398395
Dongying Zhang, doctor
study director · First Affiliated Hospital of Chongqing Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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