Investigating the role of bilirubin in heart failure with preserved ejection fraction
Effect of Bilirubin on Prognosis in Heart Failure With Preserved Ejection Fraction
This study is trying to see if measuring bilirubin levels can help predict how well people with heart failure and preserved ejection fraction will do in the future.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chongqing Medical University Academic / other |
| Locations | 1 site (Chongqing) |
| Trial ID | NCT06379152 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between direct bilirubin levels and prognosis in patients diagnosed with heart failure with preserved ejection fraction (HFpEF). HFpEF accounts for a significant portion of heart failure cases, yet effective therapies to improve outcomes are lacking. The study will assess whether direct bilirubin can serve as a predictor for adverse outcomes in this patient population, given its association with various complications related to heart failure. By analyzing bilirubin levels, the researchers hope to gain insights into the multifactorial nature of HFpEF and its prognosis.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with HFpEF.
Not a fit: Patients with left ventricular ejection fraction below 49% will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could identify bilirubin as a potential biomarker for predicting outcomes in patients with HFpEF, leading to improved management strategies.
How similar studies have performed: While previous studies have linked bilirubin levels to heart failure outcomes, the specific relationship between direct bilirubin and HFpEF prognosis remains largely unexplored, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chongqing
- The First Affiliated Hospital of Chongqing Medical University — Chongqing, China (Recruiting)
Study contacts
- Study coordinator: Dongying Zhang, doctor
- Email: zdy.chris@qq.com
- Phone: +8613608398395
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.