Status:

COMPLETED

Utility of Neutrophil Gelatinase-associated Lipocalin (NGAL) in Predicting Renal Impairment, Further Decompensation and Rehospitalization in Acutely Decompensated and Chronic Heart Failure Patients

Lead Sponsor:

The Alfred

Collaborating Sponsors:

Abbott RDx Cardiometabolic

Conditions:

Heart Failure

Eligibility:

All Genders

18+ years

Brief Summary

Acute decompensated heart failure (ADHF) is the leading cause of admission to hospital in the US, and is associated with high mortality, morbidity, and major cost to the health care system. Much of th...

Eligibility Criteria

Inclusion

  • Males and Females
  • Age \>18years
  • Confirmed written informed consent
  • Acute decompensated heart failure cohort defined as:
  • Objective evidence of heart failure (of any cause/etiology) demonstrated by typical symptoms/signs combined with an imaging modality (see appendix for criteria)
  • Requirement for intravenous diuretic whilst either an inpatient or in an emergency room setting with intravenous diuretics, vasodilators or inotropes
  • No ejection fraction cut-off will be required, ie both systolic and diastolic heart failure patients can be enrolled
  • Chronic Heart Failure cohort defined as:
  • Echocardiographic evidence of systolic or diastolic heart failure (see appendix for criteria)
  • CHF patients in Class III and class IV NYHA symptoms who have had a minimum of one acute decompensated episode in the previous six months
  • Evidence of impaired renal function (eGFR \<60 ml/min)

Exclusion

  • Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study
  • Not meeting entry criteria for ADAF (as above)
  • At the discretion of the treating physician

Key Trial Info

Start Date :

December 1 2008

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

May 1 2014

Estimated Enrollment :

106 Patients enrolled

Trial Details

Trial ID

NCT00874289

Start Date

December 1 2008

End Date

May 1 2014

Last Update

January 22 2015

Active Locations (1)

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1

Alfred Hospital

Melbourne, Victoria, Australia, 3004