NT-proBNP Measurements to Rule-out Heart Failure Among Patients With Atrial Fibrillation: A Prospective Clinical Study

NCT04125966 | Unknown DMC

• 1 other identifier: 69531
• Study Type: observational
• Target: 403
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate N-terminal pro brain natriuretic peptide (NT-proBNP) as a biomarker to rule out heart failure in patients with atrial fibrillation. Atrial fibrillation and heart failure often co-exist. Heart failure is important to identify, as part of the medical treatment for patients with atrial fibrillation can be fatal if the patient has concomitant heart failure. Performing an echocardiography is considered "gold standard" for assessing cardiac function but echocardiography may not always be readily available during acute hospitalization. The cardiac biomarker NT-proBNP can be used to rule out acute heart failure in patients with sinus rhythm. However, atrial fibrillation affects levels of NT-proBNP in the blood and it is therefore unknown, how the biomarker performs in atrial fibrillation patients.

Conditions

Atrial Fibrillation; Heart Failure

Keywords

NT-proBNP; Atrial Fibrillation; Heart Failure

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of NT-proBNP for ruling out heart failure in atrial fibrillation patients

  The negative predictive value (NPV) of NT-proBNP for ruling out heart failure in atrial fibrillation patients

  0-48 hours after admission to hospital

Secondary Outcomes (1)

• Overall diagnostic performance of NT-proBNP in detecting heart failure among atrial fibrillation patients

  0-48 hours after admission to hospital

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the Emergency Department with atrial fibrillation.

You may qualify if:

• Admission to hospital with atrial fibrillation
• On-going atrial fibrillation documented on an ECG

You may not qualify if:

• \<18 years
• Other arrhythmias than atrial fibrillation
• Hemodynamically unstable
• Terminal renal failure (in dialysis)
• Pregnancy

Sponsors & Collaborators

• University of Aarhus: lead
• Randers Regional Hospital: collaborator

Study Sites (1)

Randers Regional Hospital

Randers, 8930, Denmark

RECRUITING

Related Publications (18)

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  PMID: 12771006 BACKGROUND

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  PMID: 23465093 BACKGROUND

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  PMID: 20519241 BACKGROUND

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  PMID: 12124404 BACKGROUND

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• Budolfsen C, Schmidt AS, Lauridsen KG, Hoeks CB, Waziri F, Poulsen CB, Riis DN, Rickers H, Lofgren B. NT-proBNP cut-off value for ruling out heart failure in atrial fibrillation patients - A prospective clinical study. Am J Emerg Med. 2023 Sep;71:18-24. doi: 10.1016/j.ajem.2023.05.041. Epub 2023 Jun 7.

  PMID: 37320999 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Lithium-heparin blood samples for analysis of NT-proBNP.

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bo Løfgren, Professor, MD, PhD, FESC, FAHA

  Randers Regional Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Løfgren, Professor, MD, PhD, FESC, FAHA

CONTACT

+4578420000; bl@clin.au.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 14, 2019
• Study Start: November 11, 2019
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: October 12, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)