Bedside NT-proBNP Monitoring in Acute Heart Failure
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMao Chen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged ≥18 years.
Patients hospitalized in the cardiac intensive care unit (CCU) with a diagnosis of acute decompensated heart failure (ADHF).
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Serial NT-proBNP Measurement
Other interventionSerial 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Acute Decompensated Heart Failure Cohort1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Within 72 hours after admission to the cardiac intensive care unitSecondary outcomes
1
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.
Time frame
Within 72 hours after admission to the cardiac intensive care unit2
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.
Time frame
Within 72 hours after admission to the cardiac intensive care unitLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Mao Chen
Lead sponsor
West China Hospital
Sponsor institution
Source ClinicalTrials.gov
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