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

Completed

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT04169815

Run by

Beckman Coulter, Inc.

People needed

2370

Starts

2019-11-20

Expected to finish

2022-09-30

Last updated by the study team

2023-02-14

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Beckman Coulter Site AJ — Loma Linda, California, United States
• Beckman Coulter Site AL — Sacramento, California, United States
• Beckman Coulter Site AB — Gainesville, Florida, United States
• Beckman Coulter Site AG — Indianapolis, Indiana, United States
• Beckman Coulter Site AN — Kansas City, Kansas, United States
• Beckman Coulter Site AA — Detroit, Michigan, United States
• Beckman Coulter Site AH — St Louis, Missouri, United States
• Beckman Coulter Site AI — Albuquerque, New Mexico, United States
• Beckman Coulter Site AE — Stony Brook, New York, United States
• Beckman Coulter Site AK — Cleveland, Ohio, United States
• Beckman Coulter Site AF — Columbus, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Beckman Coulter Site AC — Charleston, South Carolina, United States
• Beckman Coulter Site AD — Nashville, Tennessee, United States
• Beckman Coulter Site AM — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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