Biomarker Panel Development for Early Identification of Worsening Heart Failure and Improved Post-acute Care
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorChang Gung Memorial Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Patients currently receiving maintenance hemodialysis or peritoneal dialysis.
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.
Trial population
Outpatients with chronic heart failure
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
800 Participants
are grouped into 1 trial groupGroup A: outpatients with chronic heart failure
Trial outcomes
Primary outcomes
1
Recurrent worsening heart failure (HF) event burden
Recurrent worsening heart failure (HF) event burden within 36 months after enrollment. Events include: 1. Hospitalization for worsening HF 2. HF worsening treated at emergency or outpatient clinic 3. intensive diuretic care event 4. All-cause death
Time frame
within 36 months after enrollmentSecondary outcomes
1
Composite events
1. First hospitalization for worsening heart failure, emergency heart failure care, or all-cause death within 36 months 2. Number of heart failure hospitalizations, number of emergency/unexpected care visits, and total days of hospitalization within 36 months
Time frame
within 36 months after enrollmentLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Chang Gung Memorial Hospital
Lead sponsor
National Taiwan University Hospital
Collaborator
Mackay Memorial Hospital
Collaborator
Cheng-Hsin General Hospital
Collaborator
Source ClinicalTrials.gov
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