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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06379152
Other study ID # 2024-04-16
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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