ANZCTR - Registration

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Trial details imported from ClinicalTrials.gov

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

Registration number

NCT00874289

Ethics application status

Date submitted

1/04/2009

Date registered

2/04/2009

Date last updated

22/01/2015

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]

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

Condition category

Condition code

Cardiovascular

Coronary heart disease

Cardiovascular

Other cardiovascular diseases

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Other interventions - NGAL kit

Acute heart failure patients -

Chronic heart failure patients -

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

Intervention code [1]

Other interventions

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

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]

12 months

Secondary outcome [1]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/12/2008

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

1/05/2014

Sample size

Target

Accrual to date

Final

106

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Alfred Hospital - Melbourne

Recruitment postcode(s) [1]

3004 - Melbourne

Funding & Sponsors

Primary sponsor type

Other

Name

The Alfred

Address

Country

Other collaborator category [1]

Other

Name [1]

Abbott RDx Cardiometabolic

Address [1]

Country [1]

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/study/NCT00874289

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Henry Krum, MBBS FRACP PhD

Address

Monash University / Alfred Hospital

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00874289

Trial Review

Registering a new trial?

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