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

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ClinicalTrials.gov Identifier: NCT04125966
Recruitment Status : Not yet recruiting
First Posted : October 14, 2019
Last Update Posted : October 14, 2019
Sponsor:
Collaborator:
Randers Regional Hospital
Information provided by (Responsible Party):
University of Aarhus

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.

Condition or disease
Atrial Fibrillation Heart Failure

Detailed Description:

Background and hypothesis:

Atrial fibrillation is the most common cardiac arrhythmia with a prevalence of approximately 2% in the general population and even higher among elderlies. Atrial fibrillation is associated with an increased morbidity, mortality and risk of heart failure. Patients with atrial fibrillation are at risk of developing tachycardia-induced cardiomyopathy. Furthermore, heart failure of any other cause and atrial fibrillation often co-exist and these patients are at high risk of adverse outcomes and hospitalization. Therefore, early identification of heart failure among patients with atrial fibrillation is important in order to initiate the optimal treatment strategy. However, as recent onset atrial fibrillation and heart failure may present with similar symptoms, excluding heart failure in atrial fibrillation patients is a clinical challenge. The gold standard for evaluating heart failure is echocardiography. However, the access to echocardiographic evaluation may be limited in some hospitals receiving patients with atrial fibrillation. In situations where acute heart failure cannot be ruled-out, clinicians may choose to prescribe digoxin instead of e.g. beta blockers that are preferred for heart rate control. Digoxin is associated with a substantially higher mortality in large cohorts and is not recommended as a first line treatment. Methods other than echocardiography to rule-out heart failure in patients with atrial fibrillation is therefore warranted.

N-terminal pro-brain natriuretic peptide (NT-proBNP) is an established biomarker in identifying and determining long-term prognosis of heart failure in the general population. However, levels of NT-proBNP are known to be higher in atrial fibrillation patients, regardless of underlying structural heart disease.Therefore, it is not possible to rule-out heart failure in patients presenting to the Emergency Department with new-onset atrial fibrillation using existing algorithms for NT-proBNP and heart failure. Accordingly, the aim of this study is to prospectively measure NT-proBNP in atrial fibrillation patients to identify a NT-proBNP threshold making heart failure unlikely.

Perspectives: This study will evaluate if NT-proBNP may be feasible to rule-out heart failure in patients presenting with atrial fibrillation without the use of echocardiography. Early rule-out of heart failure will allow the use of more safe medication for rate control e.g. beta-blockers instead of digoxin.


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Study Type : Observational
Estimated Enrollment : 403 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: NT-proBNP Measurements to Rule-out Heart Failure Among Patients With Atrial Fibrillation: A Prospective Clinical Study
Estimated Study Start Date : October 7, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Diagnostic performance of NT-proBNP for ruling out heart failure in atrial fibrillation patients [ Time Frame: 0-48 hours after admission to hospital ]
    The negative predictive value (NPV) of NT-proBNP for ruling out heart failure in atrial fibrillation patients


Secondary Outcome Measures :
  1. Overall diagnostic performance of NT-proBNP in detecting heart failure among atrial fibrillation patients [ Time Frame: 0-48 hours after admission to hospital ]
    Sensitivity, specificity and the positive predictive value (PPV)


Biospecimen Retention:   Samples Without DNA
Lithium-heparin blood samples for analysis of NT-proBNP.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting to the Emergency Department with atrial fibrillation.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04125966


Contacts
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Contact: Bo Løfgren, Professor, MD, PhD, FESC, FAHA +4578420000 bl@clin.au.dk

Locations
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Denmark
Randers Regional Hospital Not yet recruiting
Randers, Denmark, 8930
Contact: Bo Løfgren, MD, PhD    +45 78420000    bl@clin.au.dk   
Principal Investigator: Bo Løfgren, MD, PhD, FESC, FAHA         
Principal Investigator: Cecilie Budofsen, MB         
Sub-Investigator: Hans Rickers, MD         
Sub-Investigator: Anders S Schmidt, MD         
Sub-Investigator: Kasper G Lauridsen, MD         
Sub-Investigator: Camilla Bang, MD         
Sponsors and Collaborators
University of Aarhus
Randers Regional Hospital
Investigators
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Principal Investigator: Bo Løfgren, Professor, MD, PhD, FESC, FAHA Randers Regional Hospital

Publications:

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT04125966     History of Changes
Other Study ID Numbers: 69531
First Posted: October 14, 2019    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
NT-proBNP
Atrial Fibrillation
Heart Failure
Additional relevant MeSH terms:
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Heart Failure
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes