Outpatients With Chronic Heart FailureNCT07838766
Biomarker Panel Development for Early Identification of Worsening Heart Failure and Improved Post-acute Care
An observational study of Outpatients With Chronic Heart Failure and Heart Failure Chronic, run by Chang Gung Memorial Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Outpatients With Chronic Heart Failure, Heart Failure Chronic
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 18 Sep 2026to 31 Oct 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients with chronic heart failure
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the detailed description
- Background:
Heart failure is a complex syndrome. Any abnormality in cardiac structure or function that affects ventricular congestion or ejection can lead to heart failure. Clinically, heart failure is classified into four categories based on the presence or absence of abnormal left ventricular ejection fraction (LVEF): heart failure with reduced ejection fraction (HFrEF), heart failure with mildly reduced ejection fraction (HFmrEF), heart failure with normal left ventricular ejection fraction (LVEF ≥ 50%), and heart failure with improved ejection fraction (HFimpEF) (previously LVEF ≤ 40%, followed by follow-up to LVEF > 40%). The New York Heart Association functional classification (NYHA Fc) further classifies participants into grades I through IV based on the degree of limitation in physical activity. Participants diagnosed with HFrEF who exhibit symptoms of NYHA Fc grades 2 to 4 require guideline-directed medical therapy (GDMT). However, a good assessment strategy for long-term follow-up after treatment remains lacking.
Among existing diagnostic and treatment strategies, NT-proBNP is the most widely used biomarker for diagnosis and prognostic assessment. However, its ability to identify early abnormalities of heart failure relapse, quantify metabolic abnormalities caused by heart failure, and detect endogenous toxicities caused by heart failure is still insufficient, and its assessment of heart failure prognosis is also imprecise. Elevated blood concentrations of phenylalanine and its metabolite phenylpyruvate are currently considered highly relevant to the pathophysiological mechanisms of heart failure exacerbation and can lead to the accumulation of phenylalanine and its downstream metabolite phenylpyruvate in the body fluids and tissues of heart failure patients, further worsening cardiac function. Furthermore, these metabolic disorders are closely associated with oxidative stress, mitochondrial dysfunction, and impaired energy synthesis. These alterations have been confirmed in animal models and clinical patients. They hold great potential as biomarkers for long-term monitoring by capturing early metabolic abnormalities and endogenous toxicities in heart failure.
Therefore, this study focuses on phenylalanine and phenylpyruvate metabolites to assess their correlation with patient prognosis. In another part, the investigators used the Chang Gung database for data analysis and integrated metabolite testing and clinical data into a "Risk Score" to identify high-risk patients. This aims to provide heart failure patients with more precise metabolic assessment and clinical management tools, thereby improving their quality of life and reducing disease-related mortality and hospitalization rates.
II. Objectives:
- To uniformly quantify phenylalanine and phenylpyruvate using high-order mass spectrometry and verify their correlation with the worsening of heart failure.
- To use the developed "Risk Score" in prospective, multicenter, observational validation studies (including Chang Gung Memorial Hospital, Mackay Memorial Hospital, Cheng Hsin General Hospital, and National Taiwan University Hospital) to assess its clinical predictive ability, calibration, discrimination, and cross-center generalization ability in participants with chronic outpatient heart failure.
III. Methods The investigators will enroll participants at outpatient clinic at different hospitals. Then, fasting blood (3 ml) will be collected once to get the plasma after centrifugation. Phenylpyruvate (PPA) concentration will be measured by liquid chromatography-mass spectrometry (LC-MS/MS).
Based on clinical information and the blood levels of NT-proBNP and PPA, a risk score will be calculated.
For clinical outcomes, the investigators will follow up participants' events of recurrent worsening heart failure, which will be explained in the primary and secondary outcome section.
The investigators will do statistical analysis to see the prognostic value of PPA concentrations and the risk scores.
- Keywords
- outpatients, chronic heart failure, biomarker, phenylalanine, phenylpyruvate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| outpatients with chronic heart failure | Inclusion Criteria: * 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent worsening heart failure (HF) event burden
Recurrent worsening heart failure (HF) event burden within 36 months after enrollment. Events include:
- Hospitalization for worsening HF
- HF worsening treated at emergency or outpatient clinic
- intensive diuretic care event
- All-cause death
Measured: within 36 months after enrollment
Secondary outcomes (1)
Composite events
- First hospitalization for worsening heart failure, emergency heart failure care, or all-cause death within 36 months
- Number of heart failure hospitalizations, number of emergency/unexpected care visits, and total days of hospitalization within 36 months
Measured: within 36 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start18 Sep 2026 (estimated)
- Primary completion31 Oct 2030 (estimated)
- Study completion31 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Outpatients With Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Mackay Memorial Hospital, Cheng-Hsin General Hospital
- Responsible party
- Principal investigator, CHAO-HUNG WANG, MD, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838766
- Sponsor's protocol ID
- 202500252B0C6002
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07838766
- Acronym / sponsor ID
- 202500252B0C6002
- Keywords
- outpatients, chronic heart failure, biomarker, phenylalanine, phenylpyruvate
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Mackay Memorial Hospital, Cheng-Hsin General Hospital
- Study start
- 18 Sep 2026 (estimated)
- Primary completion
- 31 Oct 2030 (estimated)
- Study completion
- 31 Oct 2030 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Background:
Heart failure is a complex syndrome. Any abnormality in cardiac structure or function that affects ventricular congestion or ejection can lead to heart failure. Clinically, heart failure is classified into four categories based on the presence or absence of abnormal left ventricular ejection fraction (LVEF): heart failure with reduced ejection fraction (HFrEF), heart failure with mildly reduced ejection fraction (HFmrEF), heart failure with normal left ventricular ejection fraction (LVEF ≥ 50%), and heart failure with improved ejection fraction (HFimpEF) (previously LVEF ≤ 40%, followed by follow-up to LVEF > 40%). The New York Heart Association functional classification (NYHA Fc) further classifies participants into grades I through IV based on the degree of limitation in physical activity. Participants diagnosed with HFrEF who exhibit symptoms of NYHA Fc grades 2 to 4 require guideline-directed medical therapy (GDMT). However, a good assessment strategy for long-term follow-up after treatment remains lacking.
Among existing diagnostic and treatment strategies, NT-proBNP is the most widely used biomarker for diagnosis and prognostic assessment. However, its ability to identify early abnormalities of heart failure relapse, quantify metabolic abnormalities caused by heart failure, and detect endogenous toxicities caused by heart failure is still insufficient, and its assessment of heart failure prognosis is also imprecise. Elevated blood concentrations of phenylalanine and its metabolite phenylpyruvate are currently considered highly relevant to the pathophysiological mechanisms of heart failure exacerbation and can lead to the accumulation of phenylalanine and its downstream metabolite phenylpyruvate in the body fluids and tissues of heart failure patients, further worsening cardiac function. Furthermore, these metabolic disorders are closely associated with oxidative stress, mitochondrial dysfunction, and impaired energy synthesis. These alterations have been confirmed in animal models and clinical patients. They hold great potential as biomarkers for long-term monitoring by capturing early metabolic abnormalities and endogenous toxicities in heart failure.
Therefore, this study focuses on phenylalanine and phenylpyruvate metabolites to assess their correlation with patient prognosis. In another part, the investigators used the Chang Gung database for data analysis and integrated metabolite testing and clinical data into a "Risk Score" to identify high-risk patients. This aims to provide heart failure patients with more precise metabolic assessment and clinical management tools, thereby improving their quality of life and reducing disease-related mortality and hospitalization rates.
II. Objectives:
- To uniformly quantify phenylalanine and phenylpyruvate using high-order mass spectrometry and verify their correlation with the worsening of heart failure.
- To use the developed "Risk Score" in prospective, multicenter, observational validation studies (including Chang Gung Memorial Hospital, Mackay Memorial Hospital, Cheng Hsin General Hospital, and National Taiwan University Hospital) to assess its clinical predictive ability, calibration, discrimination, and cross-center generalization ability in participants with chronic outpatient heart failure.
III. Methods The investigators will enroll participants at outpatient clinic at different hospitals. Then, fasting blood (3 ml) will be collected once to get the plasma after centrifugation. Phenylpyruvate (PPA) concentration will be measured by liquid chromatography-mass spectrometry (LC-MS/MS).
Based on clinical information and the blood levels of NT-proBNP and PPA, a risk score will be calculated.
For clinical outcomes, the investigators will follow up participants' events of recurrent worsening heart failure, which will be explained in the primary and secondary outcome section.
The investigators will do statistical analysis to see the prognostic value of PPA concentrations and the risk scores.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| outpatients with chronic heart failure | – | –Inclusion Criteria: * 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients with chronic heart failure
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrent worsening heart failure (HF) event burden
Time frame: within 36 months after enrollment
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
1 secondary outcome
Composite events
Time frame: within 36 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Outpatients With Chronic Heart Failure and Heart Failure Chronic, run by Chang Gung Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao-Hung Wang, MD, PhD (0975360604, bearty54@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent worsening heart failure (HF) event burden (time frame: within 36 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.