Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000657921
Ethics application status
Approved
Date submitted
27/06/2011
Date registered
28/06/2011
Date last updated
7/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Study to Estimate the Week to Week and Month to Month Fluctuations of a Heart Hormone (NT-proBNP) in Patients on Dialysis
Scientific title
Week-Week and Month-Month Biological Variation and Reference Change Values of NTproBNP in the Stable Dialysis Population
Secondary ID [1] 262470 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
MONITOR - Monitoring Oscillations of NT-proBNP In guiding Therapy and predicting Outcomes in Renal disease
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiomyopathy 268162 0
Renal Dialysis 268163 0
Condition category
Condition code
Renal and Urogenital 268295 268295 0 0
Kidney disease
Cardiovascular 268296 268296 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
Within person biological variation, between person variation, and within- and between run analytic variation of a cardiac hormone (NT-proBNP) measured at weekly intervals for four weeks followed by monthly intervals for four months
Intervention code [1] 266828 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 269027 0
Within person biological variation - NT-proBNP (plasma) assayed at weekly and monthly intervals in stable dialysis patients
Timepoint [1] 269027 0
Weekly intervals for 4 weeks followed by monthly intervals for four months
Primary outcome [2] 269028 0
Between person variation - NT-proBNP (plasma) assayed at baseline
Timepoint [2] 269028 0
Baseline
Primary outcome [3] 269029 0
Within- and between run analytic variation - duplicate specimen analysis for within run variation and comparison of variation of patient and quality control specimens across multiple analytic runs for between run variation
Timepoint [3] 269029 0
5-months
Secondary outcome [1] 276841 0
Nil
Timepoint [1] 276841 0
Nil

Eligibility
Key inclusion criteria
In-centre haemo- or peritoneal dialysis patients established on a single dialysis modality for at least 90-days
Stable dialysis prescription for at least one month
Aged 18-years or older
Able to provide informed consent
Echocardiogram within 12-months of enrollment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Living renal transplantation planned within 5-months of enrolment.
Home haemodialysis
Patients on peritoneal dialysis not receiving continuous therapy (e.g. NIPD).
Permanent pacemaker and/or implantable cardiac defibrillator.
Joint replacements, orthopaedic pins, mechanical heart valves and amputations.
Any of the following events / conditions in the month prior to screening:
Admission to hospital for any cause.
Change in dry body weight target of > 1kg.
Unscheduled haemodialysis for treatment of hypertension, dyspnoea or congestive cardiac failure.
Change in dialysis prescription.
Initiation or dose alteration of angiotensin converting enzyme inhibitor, angiotensin receptor blocker, beta-blocker, or aldosterone receptor antagonist.
If has ischaemic heart disease – change in severity of angina – increased frequency and/or occurrence with lesser degrees of exertion and/or alteration in dose of anti-anginal agent(s).
If has arrhythmia – change in dose of anti-arrhythmic agent or initiation of new anti-arrhythmic agent.
Systemic infection.
Congenital heart disease (excluding haemodynamically insignificant patent foramen ovale).
Documented severe left ventricular systolic dysfunction defined as an ejection fraction less than 30% by Simpson’s rule.
Severe aortic stenosis or regurgitation.
Severe mitral stenosis or regurgitation.
Severe pulmonary hypertension (RVSP > [60 mmHg > RA]) due to any cause.
ST or non-ST segment myocardial infarction (defined as a combination of serial elevation in Troponin T and any one of new ST/T wave changes on ECG and/or symptoms of cardiac ischaemia) in the 6-months prior to screening.
Cardiac surgery and/or coronary angioplasty in the 6-months prior to screening.
Pulmonary embolism in the preceding 6-months.
Advanced malignancy.
Pregnancy.
Current immunosuppressive pharmacotherapy for any indication.

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267300 0
Charities/Societies/Foundations
Name [1] 267300 0
Princess Alexandra Research Foundation
Country [1] 267300 0
Australia
Funding source category [2] 267301 0
Charities/Societies/Foundations
Name [2] 267301 0
Kidney Health Australia
Country [2] 267301 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
Renal Department
2nd Floor, ARTS Building 31
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102
Country
Australia
Secondary sponsor category [1] 266379 0
University
Name [1] 266379 0
University of Queensland
Address [1] 266379 0
The University of Queensland
Brisbane
QLD 4072
Country [1] 266379 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269307 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 269307 0
Princess Alexandra Hospital,
199 Ipswich Road
Woolloongabba
QLD 4102
Ethics committee country [1] 269307 0
Australia
Date submitted for ethics approval [1] 269307 0
16/06/2010
Approval date [1] 269307 0
19/08/2010
Ethics approval number [1] 269307 0
HREC/10/QPAH/131

Summary
Brief summary
The aim of the study is to establish the magnitude of variation in serial measurements of a cardiac hormone (NT-proBNP) that can be attributed to homeostatic fluctuations around a set-point (biological variation). Such information will be used to inform monitoring guidelines as to the magnitude of fluctuations that are not associated with adverse outcomes at the individual level and that can be safely ignored.

The study also intends to establish the analytic performance of the most commonly used NT-proBNP assay (Roche Elecsys 2010) in the dialysis population.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 32790 0
Address 32790 0
Country 32790 0
Phone 32790 0
Fax 32790 0
Email 32790 0
Contact person for public queries
Name 16037 0
Dr Magid Fahim
Address 16037 0
Department of Nephrology
ARTS Building 31
Princess Alexandra Hospital
199 Ipswich Road, Woolloongabba, Brisbane,
QLD 4102
Country 16037 0
Australia
Phone 16037 0
+61 7 31765080
Fax 16037 0
+61 7 31765480
Email 16037 0
magid_fahim@health.qld.gov.au
Contact person for scientific queries
Name 6965 0
Dr Magid Fahim
Address 6965 0
Department of Nephrology
ARTS Building 31
Princess Alexandra Hospital
199 Ipswich Road, Woolloongabba, Brisbane,
QLD 4102
Country 6965 0
Australia
Phone 6965 0
+61 7 31765080
Fax 6965 0
+61 7 31765480
Email 6965 0
magid_fahim@health.qld.gov.au

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.