VITROS Immunodiagnostic Products NT-proBNP II

Completed

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT03548909

Run by

Ortho-Clinical Diagnostics, Inc.

People needed

3246

Starts

2018-06-06

Expected to finish

2019-10-17

Last updated by the study team

2020-03-09

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

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):
• Inclusion Criteria:
• 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.
• Exclusion Criteria:
• 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.

Where it is running

• Drug Research Analysis Corp — Montgomery, Alabama, United States
• University of Arizona Banner - University Medical Center South Campus — Tucson, Arizona, United States
• Westside Medical Associates of Los Angeles — Beverly Hills, California, United States
• University of California Davis Health — Sacramento, California, United States
• University of California San Diego Health — San Diego, California, United States
• Northwestern University — Evanston, Illinois, United States
• Indiana University Health Hospital (Eskenazi & Methodist) — Indianapolis, Indiana, United States
• Southern Clinical Research — Zachary, Louisiana, United States
• University of Maryland (Baltimore & St. Joseph) — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Wayne State University (Harper) — Detroit, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• William Beaumont Hospital (Royal Oak & Troy) — Royal Oak, Michigan, United States
• Clinical Research of South Nevada — Las Vegas, Nevada, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Charlotte-Mecklenburg Hospital Authority (Carolinas Healthcare System) — Charlotte, North Carolina, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• University of Cincinnati Physicians Company — Cincinnati, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Baylor College of Medicine (Ben Taub) — Houston, Texas, United States
• Sun Research Institute — San Antonio, Texas, United States
• INOVA Healthcare Services — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.