Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000836831
Ethics application status
Approved
Date submitted
8/08/2012
Date registered
8/08/2012
Date last updated
8/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Monitoring of a heart hormone (NT-proBNP) in the dialysis population for the prediction of major cardiovascular events
Scientific title
Serial NT-proBNP Monitoring in the Dialysis Population for the Prediction of Major Cardiovascular Events
Secondary ID [1] 280988 0
NIL
Universal Trial Number (UTN)
U1111-1133-3284
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:
Dialysis 287114 0
Cardiomyopathy 287115 0
Heart Failure 287116 0
Sudden Cardiac Death 287117 0
Kidney Disease 287123 0
Condition category
Condition code
Renal and Urogenital 287437 287437 0 0
Kidney disease
Cardiovascular 287438 287438 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
N-terminal pro B-type Natriuretic Peptide (NT-proBNP), Bioimpedance, Framingham Truncated Heart Failure Score - observed monthly for 24-months
Intervention code [1] 285435 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287702 0
Fatal and Non-fatal coronary vascular events
Timepoint [1] 287702 0
Monthly for 24-months
Primary outcome [2] 287703 0
Fatal and Non-fatal heart failure
Timepoint [2] 287703 0
Monthly for 24-months
Primary outcome [3] 287704 0
Fatal and non-fatal Arrhythmic events
Timepoint [3] 287704 0
Monthly for 24-months
Secondary outcome [1] 298657 0
Fatal and non-fatal peripheral vascular events
Timepoint [1] 298657 0
Monthly for 24-months
Secondary outcome [2] 298658 0
Death due to any cause
Timepoint [2] 298658 0
Monthly for 24-months
Secondary outcome [3] 298659 0
Hospitalisation for any cause
Timepoint [3] 298659 0
Monthly for 24-months
Secondary outcome [4] 298666 0
Deterioration in echocardiographic indices of left ventricular systolic and diastolic function
Timepoint [4] 298666 0
1-year and 2-years
Secondary outcome [5] 298667 0
Deterioration in pulse wave analysis and pulse wave velocity
Timepoint [5] 298667 0
1-year and 2-years

Eligibility
Key inclusion criteria
In-centre haemo- or peritoneal dialysis patients established on dialysis for at least 90-days
Established on a single dialysis modality for at least 30-days
Aged 18-years or older
Temporary or permanent vascular access
Able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Advanced malignancy and/or current malignancy undergoing evaluation and/or treatment – excludes skin cancers
Permanent pacemaker and/or implantable cardiac defibrillator
Limb amputee
Living donor renal transplant planned within 3-months of enrolment
Home haemodialysis
Congenital heart disease (excluding haemodynamically insignificant patent foramen ovale)
Acute renal impairment with the expectation of spontaneous recovery of renal function
Pregnancy

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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5586 0
4102

Funding & Sponsors
Funding source category [1] 285773 0
Government body
Name [1] 285773 0
National Health and Medical Research Council of Australia
Country [1] 285773 0
Australia
Funding source category [2] 285774 0
Charities/Societies/Foundations
Name [2] 285774 0
Princess Alexandra Research Foundation
Country [2] 285774 0
Australia
Funding source category [3] 285775 0
Charities/Societies/Foundations
Name [3] 285775 0
Kidney Health Australia
Country [3] 285775 0
Australia
Funding source category [4] 285776 0
Commercial sector/Industry
Name [4] 285776 0
Fresenius Medical Care
Country [4] 285776 0
Australia
Primary sponsor type
Hospital
Name
Centre for Kidney Disease Research, Princess Alexandra Hospital
Address
Department of Nephrology
Princess Alexandra Hospital
199 Ipswich Road, Woolloongabba, Brisbane,
QLD 4102
Country
Australia
Secondary sponsor category [1] 284599 0
University
Name [1] 284599 0
University of Queensland
Address [1] 284599 0
The University of Queensland
Brisbane QLD 4072
Country [1] 284599 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287786 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 287786 0
Centres for Health Research
Level 2 Building 35, Princess Alexandra Hospital
Ipswich Road, Woolloongabba Qld 4102
Ethics committee country [1] 287786 0
Australia
Date submitted for ethics approval [1] 287786 0
Approval date [1] 287786 0
19/01/2011
Ethics approval number [1] 287786 0
HREC/10/QPAH/303
Ethics committee name [2] 287787 0
University of Queensland
Ethics committee address [2] 287787 0
Human Ethics Office
Research and Innovation Division
Cumbrae-Stewart (Building 72)
The University of Queensland
Brisbane, QLD 4072
Ethics committee country [2] 287787 0
Australia
Date submitted for ethics approval [2] 287787 0
Approval date [2] 287787 0
28/04/2011
Ethics approval number [2] 287787 0
2011000484

Summary
Brief summary
Compared with the general population, dialysis patients have a 100-fold increased risk of dying from heart disease which has remained unchanged over the last decade. The main factor which predicts this risk in dialysis patients is abnormal heart muscle structure and function. Excess body fluid and high blood pressure are critical risk factors leading to these heart abnormalities. Current tests to identify dialysis patients at high risk are quite inaccurate and optimum blood pressure/fluid targets remain undefined. There is an urgent need for a blood test that accurately detects the early stages of heart injury to enable effective treatments. NT-proBNP is a heart hormone released during heart stress and early studies suggest it can predict which dialysis patients do poorly. The aim of our research is to develop a monitoring guideline based on regular testing of NT-proBNP to identify high-risk dialysis patients early. This would enable treatment before a serious medical complication occurs, potentially improving patient outcomes on dialysis. We will achieve this by testing NT-proBNP monthly in a group of 150 dialysis patients for 2-years, and correlating changes in the hormone levels with changes in patient symptoms, their health, body fluid state, and heart structure and function.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34548 0
Address 34548 0
Country 34548 0
Phone 34548 0
Fax 34548 0
Email 34548 0
Contact person for public queries
Name 17795 0
Dr Magid Fahim
Address 17795 0
Department of Nephrology,
2nd Floor, ARTS Building 31,
Princess Alexandra Hospital,
199 Ipswich Road,
Woolloongabba, Brisbane, QLD 4103
Country 17795 0
Australia
Phone 17795 0
+61731765080
Fax 17795 0
Email 17795 0
magid_fahim@health.qld.gov.au
Contact person for scientific queries
Name 8723 0
Dr Magid Fahim
Address 8723 0
Department of Nephrology,
2nd Floor, ARTS Building 31,
Princess Alexandra Hospital,
199 Ipswich Road,
Woolloongabba, Brisbane, QLD 4103
Country 8723 0
Australia
Phone 8723 0
+61731765080
Fax 8723 0
Email 8723 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

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