Heart FailureANGLE-HFNCT00874289
Utility of Neutrophil Gelatinase-associated Lipocalin (NGAL) in Predicting Renal Impairment, Further Decompensation and Rehospitalization in Acutely Decompensated and Chronic Heart Failure Patients
An observational study of Heart Failure, run by The Alfred at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- NGAL kit
- How many people
- 106 participants
- Where
- 1 siteAustralia
- Study dates
- Dec 2008to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute and chronic heart failure
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utility of NGAL in Predicting Renal Impairment, Further Decompensation & Rehospitalization in Acutely Decompensated & Chronic Heart Failure Patients
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.
Read more
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.
- Conditions
- Heart Failure
- Being tested
- NGAL kit
- Keywords
- NGAL, Heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGAL kitOther
Kit to test NGAL levels in heart failure patients
| Study group | Role | What they receive |
|---|---|---|
| Acute heart failure patients | Not described Receives: Other: NGAL kit | |
| Chronic heart failure patients | Not described Receives: Other: NGAL kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startDec 2008
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Alfred
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott RDx Cardiometabolic
- Responsible party
- Principal investigator, Henry Krum, The Alfred
- Investigators
- Henry Krum, MBBS FRACP PhD, Principal investigator, Monash University / Alfred Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874289
- Sponsor's protocol ID
- CP-01/08
- Acronym
- ANGLE-HF
- Status last verified
- Jan 2015
- First submitted
- 1 Apr 2009
- Last updated
- 22 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of NGAL in Predicting Renal Impairment, Further Decompensation & Rehospitalization in Acutely Decompensated & Chronic Heart Failure Patients
- ClinicalTrials.gov ID
- NCT00874289
- Acronym / sponsor ID
- ANGLE-HF / CP-01/08
- Conditions
- Heart Failure
- Keywords
- NGAL, Heart failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- The AlfredUniversity, hospital or other
- Collaborators
- Abbott RDx Cardiometabolic
- Study start
- Dec 2008
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 2 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute heart failure patients | – | Other: NGAL kit |
| Chronic heart failure patients | – | Other: NGAL kit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute and chronic heart failure
Key inclusion criteria (11 listed)
- Males and Females
- Age >18years
- Confirmed written informed consent
- Acute decompensated heart failure cohort defined as:
- Chronic Heart Failure cohort defined as:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NGAL kitKit to test NGAL levels in heart failure patients | Other | Acute heart failure patients, Chronic heart failure patients |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry Krum, MBBS FRACP PhD principal investigator
Monash University / Alfred Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by The Alfred at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2015.