Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000137594
Ethics application status
Approved
Date submitted
19/04/2006
Date registered
20/04/2006
Date last updated
20/04/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Renal impairment in decompensated heart failure.
Scientific title
A longitudinal cohort study to describe the severity, incidence, nature, and evolution of renal impairment over 12 months in individuals hospitalised with decompensated heart failure.
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Decompensated heart failure 1105 0
Acute renal failure 1106 0
Condition category
Condition code
Renal and Urogenital 1185 1185 0 0
Other renal and urogenital disorders
Cardiovascular 1186 1186 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a longitudinal prospective cohort study of individuals hospitalised with decompensated heart failure. Unselected consecutive patients admitted to a tertiary hospital with the primary diagnosis of heart failure will be followed for 12 months. Renal function (measured glomerular filtration rate) and renal blood flow will be measured at selected timepoints during admission and at 6 months, concurrent with detailed measurements of cardiac status (echocardiogram and neurohormonal profile).
Intervention code [1] 989 0
None
Comparator / control treatment
No comparator.
Control group

Outcomes
Primary outcome [1] 1597 0
Prospective systematic documentation of the prevalence of renal dysfunction in an unselected population hospitalised with decompensated heart failure
Timepoint [1] 1597 0
Measured during index hospitalisation and at 6 and 12 months follow up.
Primary outcome [2] 1598 0
Prospective systematic documentation of the incidence of renal dysfunction in an unselected population hospitalised with decompensated heart failure
Timepoint [2] 1598 0
Measured during index hospitalisation and at 6 and 12 months follow up.
Primary outcome [3] 1599 0
Prospective systematic documentation of the severity of renal dysfunction in an unselected population hospitalised with decompensated heart failure
Timepoint [3] 1599 0
Measured during index hospitalisation and at 6 and 12 months follow up.
Primary outcome [4] 1600 0
Prospective systematic documentation of the evolution of renal dysfunction in an unselected population hospitalised with decompensated heart failure
Timepoint [4] 1600 0
Measured during index hospitalisation and at 6 and 12 months follow up.
Secondary outcome [1] 2894 0
1) To examine the diagnostic and prognostic utility of plasma and urine biomarkers of acute kidney injury in decompensated heart failure.
Timepoint [1] 2894 0
During admission and at 6 months follow up.
Secondary outcome [2] 2895 0
2) To describe the changes in renal blood flow in human decompensated heart failure.
Timepoint [2] 2895 0
At admission and at 6 months follow up.
Secondary outcome [3] 2896 0
3) To examine the 6- and 12-month renal outcomes after hospitalisation with heart failure and their relationship to cardiac function.
Timepoint [3] 2896 0

Eligibility
Key inclusion criteria
1) All individuals hospitalised at a tertiary-level hospital with the primary diagnosis of decompensated heart failure.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Severe stenotic valvular disease2) Women of childbearing age3) Exposure to iodinated contrast during the hospital admission4) Contraindication to magnetic resonance imaging.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 303 0
New Zealand
State/province [1] 303 0

Funding & Sponsors
Funding source category [1] 1296 0
Government body
Name [1] 1296 0
Health Research Council of New Zealand
Country [1] 1296 0
New Zealand
Funding source category [2] 1297 0
University
Name [2] 1297 0
Christchurch Cardioendocrine Research Group
Country [2] 1297 0
New Zealand
Primary sponsor type
Individual
Name
Professor Mark Richards, Professor in Medicine, Christchurch School of Medicine and Health Sciences
Address
Country
New Zealand
Secondary sponsor category [1] 1145 0
University
Name [1] 1145 0
Christchurch School of Medicine and Health Sciences
Address [1] 1145 0
Country [1] 1145 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2626 0
Christchurch School of Medicine and Health Sciences Ethics
Ethics committee address [1] 2626 0
Ethics committee country [1] 2626 0
New Zealand
Date submitted for ethics approval [1] 2626 0
Approval date [1] 2626 0
Ethics approval number [1] 2626 0
Ethics committee name [2] 2627 0
Upper South B Regional Ethics Committee
Ethics committee address [2] 2627 0
Ethics committee country [2] 2627 0
New Zealand
Date submitted for ethics approval [2] 2627 0
Approval date [2] 2627 0
Ethics approval number [2] 2627 0
URB/06/02/008

Summary
Brief summary
This is an observational study of individuals who require hospital admission for severe heart failure. At admission and at 6 and 12 months of community follow up detailed measurement of both heart and kidney function will describe the nature, severity and frequency of kidney failure. The study aims to determine the important predictors of kidney impairment in severe heart failure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35809 0
Address 35809 0
Country 35809 0
Phone 35809 0
Fax 35809 0
Email 35809 0
Contact person for public queries
Name 10178 0
Dr Suetonia Palmer
Address 10178 0
Christchurch School of Medicine and Health Sciences
PO Box 4345
Christchurch
Country 10178 0
New Zealand
Phone 10178 0
+64 3 3640496
Fax 10178 0
+64 3 3641115
Email 10178 0
[email protected]
Contact person for scientific queries
Name 1106 0
Dr Suetonia Palmer
Address 1106 0
Christchurch School of Medicine and Health Sciences
PO Box 4345
Christchurch
Country 1106 0
New Zealand
Phone 1106 0
+64 3 3641116
Fax 1106 0
+64 3 3641115
Email 1106 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.