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

Heart Failure With Preserved Ejection Fraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06379152
• Other study ID #: 2024-04-16
• Status: Recruiting
• Start date: September 20, 2020
• Est. completion date: July 1, 2024

Study information

• Verified date: April 2024
• Source: Chongqing Medical University
• Contact: Dongying Zhang, doctor
• Phone: +8613608398395
• Email: zdy.chris[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 1, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction
• Prognathism

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The level of direct bilirubin	The level of direct bilirubin	The day when patients on admission
Primary	a composite of heart failure rehospitalization or all-cause mortality	a composite of heart failure rehospitalization or all-cause mortality	In an average of 3 year after discharge
Secondary	heart failure rehospitalization	heart failure rehospitalization	In an average of 3 year after discharge
Secondary	all-cause mortality	all-cause mortality	In an average of 3 year after discharge