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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by The Alfred
Sponsor:
Collaborator:
Biosite
Information provided by (Responsible Party):
Henry Krum, The Alfred
ClinicalTrials.gov Identifier:
NCT00874289
First received: April 1, 2009
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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 this cost relates to prolonged hospitalizations from acute deterioration in kidney function (AKI), which in turn is associated with further cardiovascular events such as recurrent ADHF. Strategies for early detection minimization and prevention of AKI would therefore be of tremendous benefit to both the patient and the health care system.

A common reason for hospitalization in ADHF is that of altered volume status and renal impairment. Also, many patients with ADHF have underlying hypertension and/or a recent acute coronary syndrome. Hypertension, diabetes and chronic kidney disease (CKD) are independent risk factors for cardiovascular disease, and diabetes is the leading cause of CKD. Therefore, patients presenting with ADHF are at high risk for CV events, more so if they develop AKI. Therefore, strategies to detect changes in renal status early may allow for more rapid intervention with appropriate drug and other therapies to attenuate AKI and subsequent complications, which may in turn result in prevention of early readmissions with HF.

Most ADHF patients have underlying chronic heart failure (CHF). CHF is a major cost to the health care system. About two thirds of this cost relates to hospitalization for acute deterioration in heart failure (HF). Strategies to minimize or prevent HF hospitalization therefore are of tremendous benefit to both the patient and the health care system.

The most frequent reason for hospitalization in a CHF patient is that of altered volume status and renal impairment. Therefore, as with ADHF, strategies for early detection of changes in renal status may allow for intervention with appropriate drug and other therapies to attenuate, or even prevent, the need for the patient to return to hospital.

Many approaches have been studied in relation to this concept. Deterioration in renal function is a harbinger of a need for hospitalization, and indeed a predictor of medium term mortality. However, current measures of renal function are relatively crude with a considerable lag between an insult to the kidney and its translation to a measurable deterioration in renal function reflected by worsening serum creatinine. Thus, diagnostic tests that evaluate renal injury which are modulated early in the time course of this process may have considerable utility not only in the ADHF setting but also in predicting decompensation in the CHF setting.


Condition Intervention
Heart Failure
Other: NGAL kit

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Utility of NGAL in Predicting Renal Impairment, Further Decompensation & Rehospitalization in Acutely Decompensated & Chronic Heart Failure Patients

Resource links provided by NLM:


Further study details as provided by The Alfred:

Primary Outcome Measures:
  • To assess the utility of NGAL in predicting death, rehospitalisation or deterioration of renal function (increase in creatinine of >0.3 mmol/L) at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the utility of NGAL in predicting subsequent HF rehospitalisation and predicting clinical deterioration, ie worsening symptoms and/or signs (based on NYHA class) at 30, 90 days (ADHF patients), 6 months and 12 months (CHF patients) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood and urine samples are being collected.


Estimated Enrollment: 200
Study Start Date: December 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Acute heart failure patients Other: NGAL kit
Kit to test NGAL levels in heart failure patients
Chronic heart failure patients Other: NGAL kit
Kit to test NGAL levels in heart failure patients

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Acute and chronic heart failure

Criteria

Inclusion Criteria:

  1. Males and Females
  2. Age >18years
  3. Confirmed written informed consent
  4. 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
  5. 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 Criteria:

  1. 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
  2. Not meeting entry criteria for ADAF (as above)
  3. At the discretion of the treating physician
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874289

Contacts
Contact: Henry Krum, MBBS FRACP PhD +61 3 9903 0042 henry.krum@med.monash.edu.au

Locations
Australia, Victoria
Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Henry Krum, MBBS FRACP PhD    +61 3 9903 0042    henry.krum@med.monash.edu.au   
Principal Investigator: Henry Krum, MBBS FRACP PhD         
Sponsors and Collaborators
The Alfred
Biosite
Investigators
Principal Investigator: Henry Krum, MBBS FRACP PhD Monash University / Alfred Hospital
  More Information

No publications provided

Responsible Party: Henry Krum, Prof Henry Krum, The Alfred
ClinicalTrials.gov Identifier: NCT00874289     History of Changes
Other Study ID Numbers: CP-01/08
Study First Received: April 1, 2009
Last Updated: May 29, 2013
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by The Alfred:
NGAL
Heart failure

Additional relevant MeSH terms:
Heart Failure
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 29, 2014