NCT07838766Not yet recruiting
Biomarker Panel Development for Early Identification of Worsening Heart Failure and Improved Post-acute Care
Integration of Metabolic Assessment on Phenylalanine Axis and Clinical Databank-based Artificial Intelligence Computation in Heart Failure: Biomarker Panel Development for Early Identification of Worsening Heart Failure and Improved Post-acute Care
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
Heart failure is a complex clinical syndrome with high hospitalization rates and high mortality risks. While N-terminal-pro B-type natriuretic peptide (NT-proBNP) is widely used in clinical practice to assist in diagnosis and assessment, its ability to detect prognosis in heart failure remains insufficient. Recent scientific research has found that phenylalanine in the blood and its endogenous toxic substance phenylpyruvate are closely related to impaired energy synthesis in heart muscle cells, making them highly promising next-generation long-term biomarkers. Our research team has previously developed a "risk score" prediction model that combines phenylpyruvate levels in the blood with clinical data; this project aims to further confirm its clinical value. Therefore, the investigators cordially invite heart failure patients who are being followed up in the cardiology outpatient clinic to have their "phenylalanine" and "phenylpyruvic acid" concentrations measured in a small amount of blood. This data, combined with clinical data, will be used to calculate a "Risk Score" to identify high-risk heart failure patients earlier.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 800 (estimated)
- First submitted
- 18 Sept 2026
- Start date
- 18 Sept 2026
- Primary completion date
- 31 Oct 2030
- Lead sponsor
- Chang Gung Memorial Hospital
- Diseases
- Heart failure
- NCT number
- NCT07838766
What you commit to
- Study type: Observational
- Planned participants: 800
- From 18 Sept 2026 to the primary completion date, 31 Oct 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients currently receiving maintenance hemodialysis or peritoneal dialysis.
Other illness
- Patients with other serious comorbidities that significantly impact life expectancy or survival within three months based on clinical assessment, such as terminal cancer or severe multiple organ failure.
- Patients with New York Heart Association (NYHA) class IV and unstable clinical condition requiring frequent intravenous therapy or hospitalization.
Other
- Patients who are unable to complete basic follow-up, lack key clinical data, or do not consent to the use of the specimen and data.
Who the study is looking for
- Adult men and women aged 18 to 85 years
- Patients with chronic heart failure diagnosed as stage C or D in outpatient settings. Stage definitions are based on the American Heart Association Heart Failure Classification System.
- Patients with a recorded left ventricular ejection fraction (LVEF) ≤ 40% in their medical history, but LVEF is not restricted at the time of admission to include patients with heart failure with reduced ejection fraction (HFrEF), heart failure with improved ejection fraction (HFimpEF), and those potentially progressing to heart failure with mildly reduced ejection fraction (HFmrEF)/ heart failure with preserved ejection fraction (HFpEF).
- Patients who have recently been hospitalized for acute heart failure must be discharged and have been clinically stable for at least three months before inclusion.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.