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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06379152
Enrollment
400
Registered
2024-04-23
Start date
2020-09-20
Completion date
2024-07-01
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure With Preserved Ejection Fraction, Prognathism

Keywords

Heart Failure with Preserved Ejection Fraction, Bilirubin, Prognosis

Brief 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.

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.

Interventions

None listed

Sponsors

Chongqing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The level of direct bilirubinThe day when patients on admissionThe level of direct bilirubin
a composite of heart failure rehospitalization or all-cause mortalityIn an average of 3 year after dischargea composite of heart failure rehospitalization or all-cause mortality

Secondary

MeasureTime frameDescription
heart failure rehospitalizationIn an average of 3 year after dischargeheart failure rehospitalization
all-cause mortalityIn an average of 3 year after dischargeall-cause mortality

Countries

China

Contacts

Primary ContactDongying Zhang, doctor
zdy.chris@qq.com+8613608398395

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026