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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00874289




Registration number
NCT00874289
Ethics application status
Date submitted
1/04/2009
Date registered
1/04/2009
Date last updated
20/01/2015

Titles & IDs
Public title
Utility of Neutrophil Gelatinase-associated Lipocalin (NGAL) in Predicting Renal Impairment, Further Decompensation and Rehospitalization in Acutely Decompensated and Chronic Heart Failure Patients
Scientific title
Utility of NGAL in Predicting Renal Impairment, Further Decompensation & Rehospitalization in Acutely Decompensated & Chronic Heart Failure Patients
Secondary ID [1] 0 0
CP-01/08
Universal Trial Number (UTN)
Trial acronym
ANGLE-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - NGAL kit
Other interventions - NGAL kit

Acute heart failure patients -

Chronic heart failure patients -

Acute heart failure patients -

Chronic heart failure patients -


Other interventions: NGAL kit
Kit to test NGAL levels in heart failure patients

Other interventions: NGAL kit
Kit to test NGAL levels in heart failure patients

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
12 months
Secondary outcome [1] 0 0
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)
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
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)
Timepoint [2] 0 0
12 months

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Biosite
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Biosite
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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 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.
Trial website
https://clinicaltrials.gov/show/NCT00874289
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Henry Krum, MBBS FRACP PhD
Address 0 0
Monash University / Alfred Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications