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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04169815

Enrollment

2370

Registered

2019-11-20

Start date

2019-11-20

Completion date

2022-09-30

Last updated

2023-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Natriuretic Peptide

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.

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

Interventions

DIAGNOSTIC_TESTAccess Immunodiagnostic Products

Access Natriuretic Peptide Assay

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026