An observational study in Heart Failure, sponsored by Beckman Coulter, Inc.. Completed at 17 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2025-04-23.
Sponsored by Beckman Coulter, Inc. (part of Danaher Corporation) · Observational
The goal of this study is to collect blood from subjects with a suspicion of either new onset or worsened heart failure to be used for testing studies for a new product to aid in the diagnosis of heart failure.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's enrollment of 1,100 is above the median of 200 across 1,983 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Beckman Coulter, Inc. is the lead sponsor of 31 studies on the registry; 1 is open to participants now.
First submitted after Beckman Coulter, Inc. became part of Danaher Corporation.
Counted across the registry records on this site, refreshed daily.
This study is expected to enroll approximately 1,100 subjects from intended use population. The study population (enrolled by the collective clinical sites) should reasonably represent the U.S. demographic population. Sponsor will monitor for age, race, gender representation A minimum of 400 subjects with a HF positive clinical site diagnosis need to be enrolled without being withdrawn/discontinued. Of the HF positive group, the sample size for severity assessment (> 80% power) requires a minimum of 340 subjects with a minimum of 50, 150, and 140 NYHA class II, III, and IV subjects, respectively, to detect a correlation between BNP level increase and the severity of heart failure.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Targeting subjects in the acute care setting that present with suspicion of either new onset or worsening symptoms of heart failure
Diagnostic Test: BNP
Blood collected during this study will be tested on separate IUO BNP assay on a separate protocol. No active interventions will occur during this study.
Heart failure positive subjects
Subjects with BNP value above clinical decision point
Time frame: During initial assessment in emergency department
Heart failure negative subjects
Subjects with BNP value below clinical decision point
Time frame: During initial assessment in emergency department
Plan to share: Undecided
Ran from Aug 2024 to primary completion in Feb 2025, 5 months.
Of 182 industry-sponsored observational studies under Heart Failure, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 57. This study's 5 months is below that.
Counting every sponsor, half of 975 studies reached it within 41 months; a quarter within 23 and three quarters within 89.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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