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

NCT06379152 | Recruiting

• 1 other identifier: 2024-04-16
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Preserved Ejection Fraction; Prognathism

Keywords

Heart Failure with Preserved Ejection Fraction; Bilirubin; Prognosis

Outcome Measures

Primary Outcomes (2)

• The level of direct bilirubin

  The level of direct bilirubin

  The day when patients on admission

• 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 Outcomes (2)

• heart failure rehospitalization

  In an average of 3 year after discharge

• all-cause mortality

  In an average of 3 year after discharge

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

heart failure with preserved ejection fraction (HFpEF)

You may qualify if:

• Adult aged ≥18 years old；
• Diagnosed with HFpEF.
• Diagnostic criteria including:
• left ventricular ejection fraction ≥ 50%;
• with the symptoms and/or signs of heart failure;
• 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.

You may not qualify if:

• LVEF less than 49% at any time

Sponsors & Collaborators

• Chongqing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

RECRUITING

MeSH Terms

Conditions

Prognathism

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Mandibular Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Dongying Zhang, doctor

  First Affiliated Hospital of Chongqing Medical University

  STUDY DIRECTOR

Central Study Contacts

Dongying Zhang, doctor

CONTACT

+8613608398395; zdy.chris@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 23, 2024
• Study Start: September 20, 2020
• Primary Completion: June 30, 2024
• Study Completion: July 1, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)