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

October 9, 2020 updated by: University of Aarhus
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.

Study Overview

Status

Unknown

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.

Study Type

Observational

Enrollment (Anticipated)

403

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Bo Løfgren, Professor, MD, PhD, FESC, FAHA
  • Phone Number: +4578420000
  • Email: bl@clin.au.dk

Study Locations

      • Randers, Denmark, 8930
        • Recruiting
        • Randers Regional Hospital
        • Contact:
          • Bo Løfgren, MD, PhD
          • Phone Number: +45 78420000
          • Email: bl@clin.au.dk
        • Principal Investigator:
          • Bo Løfgren, MD, PhD, FESC, FAHA
        • Principal Investigator:
          • Cecilie Budolfsen, MB
        • Sub-Investigator:
          • Hans Rickers, MD
        • Sub-Investigator:
          • Anders S Schmidt, MD
        • Sub-Investigator:
          • Kasper G Lauridsen, MD
        • Sub-Investigator:
          • Camilla Bang, MD
        • Sub-Investigator:
          • Farhad Waziri, MD, PhD
        • Sub-Investigator:
          • Christian B Poulsen, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients presenting to the Emergency Department with atrial fibrillation.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0-48 hours after admission to hospital

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
0-48 hours after admission to hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Bo Løfgren, Professor, MD, PhD, FESC, FAHA, Randers Regional Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2019

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

October 4, 2019

First Submitted That Met QC Criteria

October 11, 2019

First Posted (Actual)

October 14, 2019

Study Record Updates

Last Update Posted (Actual)

October 12, 2020

Last Update Submitted That Met QC Criteria

October 9, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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