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21-Protein blood test aims to spot hidden heart failure in the ER

NCT ID NCT04886128

Diagnosis Sponsor: Vanderbilt University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This study aims to improve how doctors diagnose acute heart failure in the emergency department. Currently, diagnosis can be slow and uncertain because symptoms like shortness of breath are vague. Researchers are testing a blood test that measures 21 different proteins to see if it can more accurately identify heart failure, helping patients get the right treatment sooner. The study involves adults who come to the ER with shortness of breath and are being checked for heart failure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
multi-marker blood test (21 proteins)
What this could lead to
If successful, this blood test could help doctors diagnose acute heart failure faster and more accurately in the emergency room, leading to quicker treatment.
What could go wrong
This is a diagnostic study, not a treatment. The test may not prove accurate enough in practice, and it is still being developed and validated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

2,469 people

The number who actually took part.

Started

Aug 2021

Finished

May 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adults (18 years or older) presenting with the chief complaint of dyspnea and in whom the ED physician is considering the diagnosis of acute HF, based on an order for measurement of NP levels (either BNP or NT-proBNP) or a chest x-ray will be included. Patients whose dyspnea is due to trauma, those who are on chronic hemodialysis, and patients whose primary presentation is consistent with acute coronary syndrome will be excluded.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

For enrollment into the prospective cohort for Outcome 3. Inclusion Criteria: 1. Willing to adhere to the study protocol 2. Able to provide written consent 3. English or Spanish speaking 4. Adult, defined as 18 years or older 5. Primary reason for presentation to the ED is dyspnea 6. ED physician is considering a diagnosis of HF, defined by ordering a NP test and/or a chest x-ray Exclusion Criteria: 1. History of end-stage renal disease for which hemodialysis is needed 2. Dyspnea due to primary presentation of an acute coronary syndrome or trauma

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Conditions

The condition(s) this trial relates to.

Dyspnea heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute heart failure Dyspnea Dyspnea; cardiac

Contacts and locations

Locations

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

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