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Access Natriuretic Peptide Assay(s) Pivotal - Emergency Department Subject Enrollment and Specimen Collection

Sponsor
Beckman Coulter, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04169815
Collaborator
(none)
1,800
Enrollment
15
Locations
34.3
Anticipated Duration (Months)
120
Patients Per Site
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the pivotal study is to collect blood specimens and clinical data from patients suspected of having Heart Failure (HF), which will be tested at a future date on Natriuretic Peptide assay(s) to validate diagnostic cutoffs and assess HF severity.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Access Immunodiagnostic Products

Detailed Description

A prospective clinical sample collection and future natriuretic peptide testing will be conducted in an emergency department only population. Patients presenting to the Emergency Department (ED) with signs and symptoms of acute heart failure will be approached for enrollment.

Clinical and laboratory data will be collected to establish product performance and clinical concordance to adjudicated clinical diagnosis. Approximately 1800 evaluable subjects at geographically dispersed sites in the US will be enrolled in the study.

Sample collection and testing of clinical samples with the Access Natriuretic Peptide assay will be performed under two separate protocols

Study Design

Study Type:
Observational
Anticipated Enrollment :
1800 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Pivotal Evaluation of the Access Natriuretic Peptdie Assay(s) as an Aid in the Diagnosis and Assessment of Severity of Acute Heart Failure - Emergency Department Subject Enrollment and Specimen Collection
Actual Study Start Date :
Nov 20, 2019
Actual Primary Completion Date :
May 31, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
ED Setting

An acute HF population enrolled at the emergency department. Testing of clinical samples will be performed with the Access natriuretic peptide assay.

Diagnostic Test: Access Immunodiagnostic Products
Access Natriuretic Peptide Assay

Outcome Measures

Primary Outcome Measures

  1. Sensitivity and Specificity of the future Natriuretic Peptide Assay(s) [Single blood draw upon study entry at day 1]

    Establish the performance of the future Natriuretic Peptide assay(s) against the adjudicated diagnosis.

Secondary Outcome Measures

  1. Heart Failure Severity Assessment [Single blood draw upon study entry at day 1 and two remote follow up visits]

    Demonstrate that the Access Natriuretic Peptide Assay may be used for assessment of heart failure severity.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Signed and dated informed consent obtained

  • Adult aged 21 years or older

  • Presenting with a clinical suspicion of acute HF

  • Subject clinical history available for review by Sponsor or delegates and FDA or other regulatory agencies

Exclusion Criteria:

  • Dyspnea clearly not secondary to HF (e.g. primary lung disease or chest trauma)

  • Stage 4 or 5 Chronic Kidney Disease (CKD)

  • Chronic dialysis

  • Participation in a clinical study that may interfere with participation in this study

  • Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beckman Coulter Site AJ Loma Linda California United States 92354
2 Beckman Coulter Site AL Sacramento California United States 95817
3 Beckman Coulter Site AB Gainesville Florida United States 32608
4 Beckman Coulter Site AG Indianapolis Indiana United States 46202
5 Beckman Coulter Site AN Kansas City Kansas United States 66160
6 Beckman Coulter Site AA Detroit Michigan United States 48202
7 Beckman Coulter Site AH Saint Louis Missouri United States 63110
8 Beckman Coulter Site AI Albuquerque New Mexico United States 87106
9 Beckman Coulter Site AE Stony Brook New York United States 11794
10 Beckman Coulter Site AK Cleveland Ohio United States 44109
11 Beckman Coulter Site AF Columbus Ohio United States 43210
12 Oregon Health and Science University Portland Oregon United States 97208-3003
13 Beckman Coulter Site AC Charleston South Carolina United States 29425
14 Beckman Coulter Site AD Nashville Tennessee United States 37235
15 Beckman Coulter Site AM Madison Wisconsin United States 53792

Sponsors and Collaborators

  • Beckman Coulter, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Beckman Coulter, Inc.
ClinicalTrials.gov Identifier:
NCT04169815
Other Study ID Numbers:
  • HF-01-19
First Posted:
Nov 20, 2019
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Beckman Coulter, Inc.
Natriuretic Peptide
Additional relevant MeSH terms:
Heart Failure
Emergencies

Study Results

No Results Posted as of Jul 19, 2022