VITROS Immunodiagnostic Products NT-proBNP II
1 other identifier
observational
3,246
1 country
25
Brief Summary
Amino Terminal pro-Brain Natriuretic Peptide (NTproBNP) is secreted in conditions of cardiac wall stress. NTproBNP levels are used in addition to clinical assessment to diagnose heart failure (HF). The purpose of this clinical study is to collect data to substantiate the use of the VITROS NT-proBNP II assay.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2018
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2018
CompletedStudy Start
First participant enrolled
June 6, 2018
CompletedFirst Posted
Study publicly available on registry
June 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 17, 2019
CompletedMarch 9, 2020
March 1, 2020
1.4 years
May 25, 2018
March 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sensitivity and Specificity of the VITROS NT-proBNP II assay
Establish the performance of the VITROS NT-proBNP II assay against the adjudicated diagnosis.
Single blood draw upon study entry 1day
Secondary Outcomes (1)
Heart Failure Severity Assessment
Single blood draw upon study entry 1 day
Study Arms (2)
ED Setting
An acute HF population enrolled at EDs. Testing of clinical samples will be performed with the VITROS Immunodiagnostic Products NT-proBNP II assay.
Outpatient Setting
A non-acute population enrolled at outpatient centers.Testing of clinical samples will be performed with the VITROS Immunodiagnostic Products NT-proBNP II assay.
Interventions
Eligibility Criteria
The ED population represents an acute HF population enrolled at Emergency Departments. Patients presenting with a suspicion of HF and acute symptoms will be approached for enrollment. The outpatient population represents a population with suspicion of HF presenting to outpatient centers. Patients presenting with a suspicion of HF will be approached for enrollment.
You may qualify if:
- Subjects must have suspicion of HF and acute symptoms at presentation.
- Subjects must be at least 22 years of age.
- Subjects must be willing and able to provide informed consent.
You may not qualify if:
- Acute symptoms clearly not secondary to HF.
- Subjects with renal disease on dialysis.
- Subjects unable to comply with the study requirements.
- Population with suspicion of HF (Outpatient Setting):
- Subjects must be at least 22 years of age.
- Subjects must be willing and able to provide informed consent.
- Subjects who present to outpatient centers with suspicion HF.
- Symptoms clearly not secondary to HF.
- Subjects with renal disease on dialysis.
- Subjects unable to comply with the study requirements.
- Subjects previously diagnosed with heart failure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Drug Research Analysis Corp
Montgomery, Alabama, 36106, United States
University of Arizona Banner - University Medical Center South Campus
Tucson, Arizona, 85724, United States
Westside Medical Associates of Los Angeles
Beverly Hills, California, 90211, United States
University of California Davis Health
Sacramento, California, 95817, United States
University of California San Diego Health
San Diego, California, 92093, United States
Northwestern University
Evanston, Illinois, 60208, United States
Indiana University Health Hospital (Eskenazi & Methodist)
Indianapolis, Indiana, 46202, United States
Southern Clinical Research
Zachary, Louisiana, 70791, United States
University of Maryland (Baltimore & St. Joseph)
Baltimore, Maryland, 21201, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Wayne State University (Harper)
Detroit, Michigan, 48201, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
William Beaumont Hospital (Royal Oak & Troy)
Royal Oak, Michigan, 48073, United States
Clinical Research of South Nevada
Las Vegas, Nevada, 89121, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Charlotte-Mecklenburg Hospital Authority (Carolinas Healthcare System)
Charlotte, North Carolina, 28203, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
University of Cincinnati Physicians Company
Cincinnati, Ohio, 45229, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Baylor College of Medicine (Ben Taub)
Houston, Texas, 77030, United States
Sun Research Institute
San Antonio, Texas, 78215, United States
INOVA Healthcare Services
Falls Church, Virginia, 22042, United States
Related Publications (6)
Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.
PMID: 27206819BACKGROUNDRichards AM, Nicholls MG, Yandle TG, Frampton C, Espiner EA, Turner JG, Buttimore RC, Lainchbury JG, Elliott JM, Ikram H, Crozier IG, Smyth DW. Plasma N-terminal pro-brain natriuretic peptide and adrenomedullin: new neurohormonal predictors of left ventricular function and prognosis after myocardial infarction. Circulation. 1998 May 19;97(19):1921-9. doi: 10.1161/01.cir.97.19.1921.
PMID: 9609085BACKGROUNDValli N, Gobinet A, Bordenave L. Review of 10 years of the clinical use of brain natriuretic peptide in cardiology. J Lab Clin Med. 1999 Nov;134(5):437-44. doi: 10.1016/s0022-2143(99)90163-4.
PMID: 10560935BACKGROUNDDarbar D, Davidson NC, Gillespie N, Choy AM, Lang CC, Shyr Y, McNeill GP, Pringle TH, Struthers AD. Diagnostic value of B-type natriuretic peptide concentrations in patients with acute myocardial infarction. Am J Cardiol. 1996 Aug 1;78(3):284-7. doi: 10.1016/s0002-9149(96)00278-0.
PMID: 8759805BACKGROUNDMcDonagh TA, Robb SD, Murdoch DR, Morton JJ, Ford I, Morrison CE, Tunstall-Pedoe H, McMurray JJ, Dargie HJ. Biochemical detection of left-ventricular systolic dysfunction. Lancet. 1998 Jan 3;351(9095):9-13. doi: 10.1016/s0140-6736(97)03034-1.
PMID: 9433422BACKGROUNDDaniels LB, Ajongwen P, Christenson RH, Clark CL, Diercks DB, Fermann GJ, Mace SE, Mahler SA, Pang PS, Rafique Z, Runyon MS, Tauras J, deFilippi CR. Clinical Performance of an N-Terminal Pro-B-Type Natriuretic Peptide Assay in Acute Heart Failure Diagnosis. J Appl Lab Med. 2025 Mar 3;10(2):325-338. doi: 10.1093/jalm/jfae107.
PMID: 39495056DERIVED
Biospecimen
Serum, Lithium Heparin, and EDTA
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Christenson, PhD
University of Maryland, College Park
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2018
First Posted
June 7, 2018
Study Start
June 6, 2018
Primary Completion
October 17, 2019
Study Completion
October 17, 2019
Last Updated
March 9, 2020
Record last verified: 2020-03