GAL Evaluation Along with B-type Natriuretic Peptide in Acutely Decompensated HF

Phase 2

• Conditions: decompensatio cordis; Heart-failure; 10019280; 10038430

• Registration Number: NL-OMON31941
• Lead Sponsor: BIOSITE Incorporate

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

(Males or females 18 years of age or older)
Patients with symptoms of new or decompensated heart failure and who will be treated with at least one dose of IV diuretic
Ability to draw blood samples

Exclusion Criteria

Acute myocardial infarction or active ischemia
Cardiogenic shock or other clinical conditions contraindicate administration of IV diuretic
History of marked renal insufficiency (serum creatinine >3.0 mg/dL), on dialysis or in imminent need of dialysis at enrollment

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is to assess the utility of the Triage NGAL<br /><br>Test - in<br /><br>conjunction with the Triage BNP test- as an aid in the early risk assessment<br /><br>for heartfailure-<br /><br>related adverse clinical outcomes (deaths, readmissions, and additional emergent<br /><br>outpatient visits) through Day 30 and Day 90 in patients presenting with acutely<br /><br>decompensated heart failure.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objective is to assess the utility of the Triage NGAL Test as an<br /><br>aid in the<br /><br>early risk assessment for renal dysfunction in patients with acutely<br /><br>decompensated heart<br /><br>failure undergoing treatment with IV diuretics.</p><br>