Specimen Collection for the Evaluation of Alere NT-pro-BNP for Alinity i System in an Emergency Department Setting for Heart Failure (LANER-HF)
N
Nicholas Harrison
Primary Investigator
Enrolling By Invitation
18-100 years
All
Phase
N/A
50 participants needed
1 Location
Brief description of study
This study will enroll patients presenting to an acute setting with signs and symptoms of heart failure (HF). Patients signs and symptoms consistent with a clinical suspicion of new onset of heart failure will be included, as well as those with a prior history of HF having signs and symptoms that are consistent with acute decompensated HF.
Detailed description of study
- A single study-specific blood sample will be obtained from each HP subject upon enrollment in the study.
- Enrolled subjects will be contacted by phone at approximately 30 days following the ED
visit or if admitted to the hospital, from the date of hospital discharge to answer
questions about their health status.
- HF Subjects will be contacted for follow-up and asked about their health status, events and have a blood
draw, physical exam and echocardiogram.
- Some subjects will have their health records reviewed at
approximately 12 months for any rehospitalization and cardiac-related medical
information and a phone call to inquire about their health status.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Heart failure, emergency medicine,
-
Age: Between 18 Years - 100 Years
-
Gender: All
Inclusion Criteria:
- Subjects presenting with signs or symptoms consistent with a clinical suspicion of new onset or acute exacerbation of heart failure.
- Symptoms may include dyspnea (shortness of breath), orthopnea (difficulty breathing when lying down), paroxysmal nocturnal dyspnea (shortness of breath while sleeping), fatigue and bilateral peripheral edema (swelling lower extremities) •
- Signs may include tachycardia, tachypnea, pulmonary rales, increased jugular venous pressure, ascites, hepatomegaly, gallop rhythm.
Exclusion Criteria:
- Severe renal insufficiency (Stage 4 and 5 CKD; eGFR < 30 mL/min/1.73m2 ) requiring dialysis.
- Dyspnea after chest trauma
- Prior participation in this study or current participation in an investigational drug study (with the exception of other IVD blood tests)
Updated on
01 Aug 2024.
Study ID: EMER-ABBOTT-LANER-HF, 12425, 09DY-02-21A01-01
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