Acute Decompensated Heart Failure (ADHF)NCT07762521
Bedside NT-proBNP Monitoring in Acute Heart Failure
An observational study of Acute Decompensated Heart Failure (ADHF), run by Mao Chen.
Trial summary
The goal of this observational study is to investigate the association between dynamic changes in NT-proBNP levels and clinical decongestion status in patients with acute decompensated heart failure (ADHF) receiving guideline-directed standard medical treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure (ADHF)
- What is being tested?
- Serial NT-proBNP Measurement
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2026to 30 Dec 2026
- How long will I take part?
- 30 Days
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients with acute decompensated heart failure admitted to the cardiac intensive care unit. All participants will receive standard guideline-directed medical treatment. The study will prospectively evaluate the relationship between dynamic changes in NT-proBNP levels and clinical decongestion status during hospitalization.
Who may be able to join
- Adults aged ≥18 years.
- Patients hospitalized in the cardiac intensive care unit (CCU) with a diagnosis of acute decompensated heart failure (ADHF).
- Presence of clinical evidence of congestion at admission, including at least one of the following:
- Symptoms or signs of volume overload (e.g., dyspnea, orthopnea, peripheral edema, elevated jugular venous pressure).
- Pulmonary congestion based on physical examination or imaging findings.
- Other clinically recognized evidence of congestion judged by the treating physician.
- Patients receiving standard guideline-directed medical treatment for acute decompensated heart failure, including intravenous diuretic therapy according to clinical practice.
- Ability to provide informed consent or availability of a legally authorized representative to provide consent.
Who cannot join
- Cardiogenic shock or requirement for immediate mechanical circulatory support.
- End-stage kidney disease requiring maintenance dialysis or renal replacement therapy at admission.
- Acute conditions requiring urgent intervention that may interfere with study assessments, including acute coronary syndrome requiring immediate revascularization or acute pulmonary embolism.
- Clinical conditions in which NT-proBNP interpretation is considered unreliable or inappropriate by the investigator.
- Expected survival of less than 72 hours, early transfer from the CCU, or inability to complete the core observation period.
- Any other condition considered inappropriate for participation by the investigator.
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: Impact of Serial Point-of-Care NT-proBNP Monitoring on Decongestion in Acute Decompensated Heart Failure: A Prospective Controlled Study
The goal of this observational study is to investigate the association between dynamic changes in NT-proBNP levels and clinical decongestion status in patients with acute decompensated heart failure (ADHF) receiving guideline-directed standard medical treatment.
The main question it aims to answer is:
Read more
Among patients with acute decompensated heart failure treated according to current clinical guidelines, are changes in NT-proBNP levels during hospitalization associated with successful clinical decongestion?
Participants will receive standard-of-care treatment for ADHF according to treating physicians' clinical decisions and current guideline recommendations. During hospitalization, serial NT-proBNP measurements and repeated assessments of congestion status will be performed to evaluate the relationship between NT-proBNP dynamics and the process of decongestion.
This study is purely observational and will not assign treatments or modify clinical management. The findings may improve understanding of the role of NT-proBNP dynamics as a marker of treatment response and provide preliminary evidence for future studies on individualized management of acute heart failure.
Read the detailed description
Acute decompensated heart failure (ADHF) is a major cause of cardiovascular hospitalization. Although aggressive decongestive therapy is the cornerstone of ADHF management, accurately assessing the degree and speed of decongestion during hospitalization remains challenging. Residual congestion at discharge is common and is associated with adverse clinical outcomes.
Current clinical practice relies on multiple parameters, including symptoms, physical examination findings, urine output, body weight changes, renal function, and imaging findings, to evaluate decongestion. Natriuretic peptides, including NT-proBNP, are widely used for diagnosis and risk stratification in heart failure; however, the clinical significance of serial NT-proBNP changes during hospitalization under contemporary guideline-directed treatment remains incompletely understood.
This prospective observational cohort study aims to evaluate the relationship between dynamic NT-proBNP changes and clinical decongestion status in patients with ADHF receiving standard medical treatment.
Adult patients admitted to the cardiac intensive care unit (CCU) with ADHF will be enrolled. All participants will receive routine guideline-directed medical therapy, including diuretic treatment and other appropriate heart failure management, according to the decisions of their treating physicians. The study team will not influence treatment selection, treatment intensity, or clinical decision-making.
During the first 72 hours after admission, serial NT-proBNP measurements will be obtained to characterize temporal changes in NT-proBNP levels. The percentage change of NT-proBNP from baseline (ΔNT-proBNP%) will be calculated. Clinical decongestion status will be assessed simultaneously using standardized clinical evaluations, including signs of systemic and pulmonary congestion and, when clinically appropriate, bedside imaging parameters.
The primary objective of this study is to determine whether dynamic changes in NT-proBNP levels are associated with achievement of clinical decongestion during hospitalization under current standard treatment.
Secondary objectives include evaluating:
The relationship between NT-proBNP trajectory and time to complete decongestion; The association between NT-proBNP changes and renal function alterations, including acute kidney injury or worsening renal function; The feasibility of serial bedside NT-proBNP monitoring in real-world clinical practice.
This study is exploratory and hypothesis-generating. It does not evaluate the efficacy of NT-proBNP-guided therapy and does not introduce any treatment intervention. The results will provide clinical evidence regarding whether NT-proBNP dynamics may serve as an objective biomarker reflecting decongestion response during ADHF hospitalization.
- Conditions
- Acute Decompensated Heart Failure (ADHF)
- Being tested
- Serial NT-proBNP Measurement
- Keywords
- ADHF, POCT NT-proBNP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial NT-proBNP MeasurementOther
Serial NT-proBNP measurements will be performed during hospitalization to assess dynamic changes in NT-proBNP levels in patients with acute decompensated heart failure receiving standard guideline-directed medical treatment. NT-proBNP measurements are collected for observational analysis only and will not determine or modify clinical treatment decisions.
| Study group | Role | What they receive |
|---|---|---|
| Acute Decompensated Heart Failure Cohort | Not described Receives: Other: Serial NT-proBNP Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in NT-proBNP Levels From Baseline During Hospitalization
The primary outcome measure is the percentage change in NT-proBNP levels from baseline during hospitalization. Serial NT-proBNP concentrations will be measured during the first 72 hours after admission using bedside NT-proBNP testing. The association between NT-proBNP changes and clinical decongestion status will be analyzed as a secondary exploratory analysis.
Measured: Within 72 hours after admission to the cardiac intensive care unit
Secondary outcomes (2)
Proportion of Participants Achieving Complete Clinical Decongestion
Complete clinical decongestion will be assessed during hospitalization using standardized clinical congestion assessments, including physical examination findings and other clinically available evaluations. The outcome measure will be the proportion of participants achieving complete clinical decongestion.
Measured: Within 72 hours after admission to the cardiac intensive care unit
Incidence of Acute Kidney Injury or Worsening Renal Function During Hospitalization
Renal function changes will be assessed based on serum creatinine levels and clinical diagnosis during hospitalization. The outcome measure will include the occurrence of acute kidney injury or worsening renal function during the observation period.
Measured: Within 72 hours after admission to the cardiac intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Decompensated Heart Failure (ADHF)Studies of the same condition, open and under way.
- 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
- 50 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Mao Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mao Chen, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762521
- Sponsor's protocol ID
- 2026-1780
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Individual data sharing
- No
Publications
Li W, Wang S, Liang Y, Wei X, Chen M. Paroxysmal hypotension and hypoxaemia caused by severe dynamic secondary mitral and tricuspid regurgitation after acute myocardial infarction. ESC Heart Fail. 2026 Feb 3;13(1):xvaf014. doi: 10.1093/eschf/xvaf014.
PubMed 41711210
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Serial Point-of-Care NT-proBNP Monitoring on Decongestion in Acute Decompensated Heart Failure: A Prospective Controlled Study
- ClinicalTrials.gov ID
- NCT07762521
- Acronym / sponsor ID
- 2026-1780
- Conditions
- Acute Decompensated Heart Failure (ADHF)
- Keywords
- ADHF, POCT NT-proBNP
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mao ChenUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 13 Aug 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.
The goal of this observational study is to investigate the association between dynamic changes in NT-proBNP levels and clinical decongestion status in patients with acute decompensated heart failure (ADHF) receiving guideline-directed standard medical treatment.
The main question it aims to answer is:
Among patients with acute decompensated heart failure treated according to current clinical guidelines, are changes in NT-proBNP levels during hospitalization associated with successful clinical decongestion?
Participants will receive standard-of-care treatment for ADHF according to treating physicians' clinical decisions and current guideline recommendations. During hospitalization, serial NT-proBNP measurements and repeated assessments of congestion status will be performed to evaluate the relationship between NT-proBNP dynamics and the process of decongestion.
This study is purely observational and will not assign treatments or modify clinical management. The findings may improve understanding of the role of NT-proBNP dynamics as a marker of treatment response and provide preliminary evidence for future studies on individualized management of acute heart failure.
Detailed description
Acute decompensated heart failure (ADHF) is a major cause of cardiovascular hospitalization. Although aggressive decongestive therapy is the cornerstone of ADHF management, accurately assessing the degree and speed of decongestion during hospitalization remains challenging. Residual congestion at discharge is common and is associated with adverse clinical outcomes.
Current clinical practice relies on multiple parameters, including symptoms, physical examination findings, urine output, body weight changes, renal function, and imaging findings, to evaluate decongestion. Natriuretic peptides, including NT-proBNP, are widely used for diagnosis and risk stratification in heart failure; however, the clinical significance of serial NT-proBNP changes during hospitalization under contemporary guideline-directed treatment remains incompletely understood.
This prospective observational cohort study aims to evaluate the relationship between dynamic NT-proBNP changes and clinical decongestion status in patients with ADHF receiving standard medical treatment.
Adult patients admitted to the cardiac intensive care unit (CCU) with ADHF will be enrolled. All participants will receive routine guideline-directed medical therapy, including diuretic treatment and other appropriate heart failure management, according to the decisions of their treating physicians. The study team will not influence treatment selection, treatment intensity, or clinical decision-making.
During the first 72 hours after admission, serial NT-proBNP measurements will be obtained to characterize temporal changes in NT-proBNP levels. The percentage change of NT-proBNP from baseline (ΔNT-proBNP%) will be calculated. Clinical decongestion status will be assessed simultaneously using standardized clinical evaluations, including signs of systemic and pulmonary congestion and, when clinically appropriate, bedside imaging parameters.
The primary objective of this study is to determine whether dynamic changes in NT-proBNP levels are associated with achievement of clinical decongestion during hospitalization under current standard treatment.
Secondary objectives include evaluating:
The relationship between NT-proBNP trajectory and time to complete decongestion; The association between NT-proBNP changes and renal function alterations, including acute kidney injury or worsening renal function; The feasibility of serial bedside NT-proBNP monitoring in real-world clinical practice.
This study is exploratory and hypothesis-generating. It does not evaluate the efficacy of NT-proBNP-guided therapy and does not introduce any treatment intervention. The results will provide clinical evidence regarding whether NT-proBNP dynamics may serve as an objective biomarker reflecting decongestion response during ADHF hospitalization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Decompensated Heart Failure Cohort | – | Other: Serial NT-proBNP Measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients with acute decompensated heart failure admitted to the cardiac intensive care unit. All participants will receive standard guideline-directed medical treatment. The study will prospectively evaluate the relationship between dynamic changes in NT-proBNP levels and clinical decongestion status during hospitalization.
Key inclusion criteria (8 listed)
- Adults aged ≥18 years.
- Patients hospitalized in the cardiac intensive care unit (CCU) with a diagnosis of acute decompensated heart failure (ADHF).
- Presence of clinical evidence of congestion at admission, including at least one of the following:
- Symptoms or signs of volume overload (e.g., dyspnea, orthopnea, peripheral edema, elevated jugular venous pressure).
- Pulmonary congestion based on physical examination or imaging findings.
Key exclusion criteria (6 listed)
- Cardiogenic shock or requirement for immediate mechanical circulatory support.
- End-stage kidney disease requiring maintenance dialysis or renal replacement therapy at admission.
- Acute conditions requiring urgent intervention that may interfere with study assessments, including acute coronary syndrome requiring immediate revascularization or acute pulmonary embolism.
- Clinical conditions in which NT-proBNP interpretation is considered unreliable or inappropriate by the investigator.
- Expected survival of less than 72 hours, early transfer from the CCU, or inability to complete the core observation period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serial NT-proBNP MeasurementSerial NT-proBNP measurements will be performed during hospitalization to assess dynamic changes in NT-proBNP levels in patients with acute decompensated heart failure receiving standard guideline-directed medical treatment. NT-proBNP measurements are collected for observational analysis only and will not determine or modify clinical treatment decisions. | Other | Acute Decompensated Heart Failure Cohort |
Primary outcome
Percentage Change in NT-proBNP Levels From Baseline During Hospitalization
Time frame: Within 72 hours after admission to the cardiac intensive care unit
The primary outcome measure is the percentage change in NT-proBNP levels from baseline during hospitalization. Serial NT-proBNP concentrations will be measured during the first 72 hours after admission using bedside NT-proBNP testing. The association between NT-proBNP changes and clinical decongestion status will be analyzed as a secondary exploratory analysis.
2 secondary outcomes
Proportion of Participants Achieving Complete Clinical Decongestion
Time frame: Within 72 hours after admission to the cardiac intensive care unit
Incidence of Acute Kidney Injury or Worsening Renal Function During Hospitalization
Time frame: Within 72 hours after admission to the cardiac intensive care unit
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 13 Aug 2026.
- Background: PubMed 41711210Li W, Wang S, Liang Y, Wei X, Chen M. Paroxysmal hypotension and hypoxaemia caused by severe dynamic secondary mitral and tricuspid regurgitation after acute myocardial infarction. ESC Heart Fail. 2026 Feb 3;13(1):xvaf014. doi: 10.1093/eschf/xvaf014.
- Individual participant dataSharing planned: No
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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 Acute Decompensated Heart Failure (ADHF), run by Mao Chen.
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 8 inclusion and 6 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 13 Aug 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 Si Wang, MD (+86-18980602792, si.wang@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in NT-proBNP Levels From Baseline During Hospitalization (time frame: Within 72 hours after admission to the cardiac intensive care unit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07762521, which also lists 1 linked publication.
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 13 Aug 2026.