Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000260729
Ethics application status
Approved
Date submitted
4/03/2013
Date registered
5/03/2013
Date last updated
11/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cardiovascular disease progression and its subsequent effect on morbity and mortality in australian patients with chronic kidney disease: a 10 year follow up
Scientific title
Cardiovascular disease progression and its subsequent effect on morbity and mortality in australian patients with chronic kidney disease: a 10 year follow up from the Landmark 1 study.
Secondary ID [1] 282056 0
Nil Known
Universal Trial Number (UTN)
U1111-1140-1292
Trial acronym
CKD Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic kidney disease 288534 0
Cardiovascular disease 288535 0
Condition category
Condition code
Renal and Urogenital 288868 288868 0 0
Kidney disease
Cardiovascular 288869 288869 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cardiovascular disease in patients suffering chronic kidney disease over a 10 year period will be assessed. Data for all patients who were originally enrolled in the Landmark 1 trial in 2000 and for whom a three year follow up was completed in 2003 will be collected for up to 10 years. Mortality and transplant data for all original participants will be obtained for the 10 year follow up from the ANZDATA Registry database. This is the database in which nephrology data from Australia and New Zealand is kept. Other data will be obtained from the Nephrology Database at the Princess Alexandra Hospital. No contact will be made with any of the subjects as most are now deceased or have had renal transplant.
Proven novel imaging techniques, such as 2D speckle (2DS) tracking, an automated, quantitative technique which allows measurement of myocardial function in all 3 planes of cardiac motion have shown promise in shorter term studies involving this patient group and will for the first time be utilised in this long term follow-up to track the cardiovascular impact of CKD. This will be done by re-measuring the original echocardiograms taken of study subjects. These echocardiograms are stored in the Cardiovascular Imaging Research Centre of the University of Queensland, School of Medicine trial database.

The previous trial was not registered in ANZCTR.
Intervention code [1] 286650 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288996 0
Mortality. Date of death and whether cardiovascular or non-cardiovascular cause will be requested from the ANZDATA database custodian.
Timepoint [1] 288996 0
Ten years from study enrollment in the Landmark 1 trial
Primary outcome [2] 288997 0
Details of major cardiac adverse events will also be obtained to the 10 year point from the Nephrology Database at the Princess Alexandra Hospital. Such events would include, myocardial infarction, heart failure, cardiac arrythmias, acute coronary syndrome.
Timepoint [2] 288997 0
Ten years from enrollment in original Landmark 1 trial
Secondary outcome [1] 301537 0
Complications related to chronic kidney disease will mainly focus on the incidence of kidney transplant after kidney failure. This data will be obtained from the ANZDATA database.
Timepoint [1] 301537 0
Ten years from enrollment in original Landmark1 trial

Eligibility
Key inclusion criteria
All participants enrolled in original Landmark 1 trial
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not enrolled in original Landmark 1 trial

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
30/05/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 706 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 6451 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 286831 0
University
Name [1] 286831 0
Cardiovascular Imaging Research Centre, School of Medicine, University of Queensland
Country [1] 286831 0
Australia
Primary sponsor type
Individual
Name
A/Prof Tony Stanton, Director
Address
CIRCUS, 4th floor, School of Medicine
Princess Alexandra Hospital
Ipswich Road
WOOLLOONGABBA QLD 4102
Country
Australia
Secondary sponsor category [1] 285621 0
Individual
Name [1] 285621 0
Dr Nikky Isbel
Nephrology Department
Address [1] 285621 0
Princess Alexandra Hospital
Ipswich Road
WOOLLOONGABBA QLD 4102
Country [1] 285621 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288896 0
Metro South Hospital and Health Service District HREC
Ethics committee address [1] 288896 0
Princess Alexandra Hospital
Ipswich Road
WOOLLOONGABBA QLD 4102
Ethics committee country [1] 288896 0
Australia
Date submitted for ethics approval [1] 288896 0
Approval date [1] 288896 0
15/11/2012
Ethics approval number [1] 288896 0
HREC/12/QPAH/459
Ethics committee name [2] 288897 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 288897 0
The University of Queensland
Cumbrae-Stewart Building
Research Road
BRISBANE QLD 4072
Ethics committee country [2] 288897 0
Australia
Date submitted for ethics approval [2] 288897 0
Approval date [2] 288897 0
13/12/2012
Ethics approval number [2] 288897 0
2012001363

Summary
Brief summary
The commonest cause of death in individuals with impaired renal function is cardiovascular disease (CVD) and in 2008 contributed to 2.3% of all deaths in Australia. According to current Australian Government predictions the incidence rate of treated end stage renal disease is projected to increase by nearly 80%—from 11 per 100,000 population in 2009 to 19 per 100,000 population in 2020. This is important as data from the Australian and New Zealand Dialysis and Transplant (ANZDATA) Registry report indicates that 40% of all deaths in patients receiving dialysis were due to CVD. This is replicated in findings from the United States Renal Data System (USRDS) where CVD mortality was 42.2%. Given this, it is now well recognised that the presence of CKD is a potent risk factor for CVD. Indeed individuals with CKD have a 10-fold to 20-fold greater risk of CVD than age- and sex-matched, healthy controls. Once on dialysis CKD patients are less likely to receive cardiovascular interventions and far more likely to die than in those without CKD.
CVD risk in this population is partially attributable to an increased presence and severity of conventional CVD risk factors such as hypertension, diabetes mellitus, dyslipidaemia and smoking. Additionally however there are other risk factors specific to CKD such as anaemia, abnormal calcium and phosphate metabolism and chronic inflammation.
Previous work carried out by our Group in this area was funded by an NHMRC Centre of Clinical Research Excellence Award (455832). The findings of this work have provided insights into the alterations in cardiovascular structure and function undergone in CKD and the pathophysiological factors underlying CVD risk. Despite the aggressive nurse-led risk factor intervention undertaken in the original study(LANDMARK1) there was little effect on cardiovascular structure, ventricular function or outcome after 2 years of follow-up. We have ascertained, through The Australia and New Zealand Dialysis and Transplant Registry, (ANZdata), that at least two thirds of the patients in this previous trial are now deceased and of those still living, a majority have proceeded to kidney transplant. We would access the ANZdata database for dates and cause of death of the deceased patients and renal transplant status. We would access the Nephrology database at the Princess Alexandra Hospital to ascertain MACE. We will analyse the baseline data for these patients to ascertain the main cardiovascular factors that predicted outcome.
Trial website
Nil
Trial related presentations / publications
Isbel NM, Haluska B, Johnson DW, Beller E, Hawley C, Marwick TH. Increased targeting of cardiovascular risk factors in patients with chronic kidney disease does not improve atheroma burden or cardiovascular function. Am Heart J 2006; 151: 745-53.

Rakhit DJ, Marwick TH, Armstrong KA, Johnson DW, Leano R, Isbel NM. Effect of aggressive risk factor modification on cardiac events and myocardial ischaemia in patients with chronic kidney disease. Heart 2006; 92: 1402–1408.
Rakhit DJ, Zhang XH, Leano R, Armstrong KA, Isbel NM, Marwick TH. Prognostic role of subclinical left ventricular abnormalities and impact of transplantation in chronic kidney disease. Am Heart J 2007; 153: 656-664.
Public notes

Contacts
Principal investigator
Name 38258 0
A/Prof Tony Stanton
Address 38258 0
UQ School of Medicine
4th floor
Princess Alexandra Hospital
Ipswich Road
WOOLLOONGABBA QLD 4102
Country 38258 0
Australia
Phone 38258 0
61 7 3176 5813
Fax 38258 0
61 7 3176 5399
Email 38258 0
[email protected]
Contact person for public queries
Name 38259 0
Mrs Julie Holliday
Address 38259 0
UQ School of Medicine
4th floor
Princess Alexandra Hospital
Ipswich Road
WOOLLOONGABBA QLD 4102
Country 38259 0
Australia
Phone 38259 0
61 7 3176 6146
Fax 38259 0
61 7 3176 5399
Email 38259 0
[email protected]
Contact person for scientific queries
Name 38260 0
A/Prof Tony Stanton
Address 38260 0
UQ School of Medicine
4th floor
Princess Alexandra Hospital
Ipswich Road
WOOLLOONGABBA QLD 4102
Country 38260 0
Australia
Phone 38260 0
61 7 3176 5813
Fax 38260 0
61 7 3176 5399
Email 38260 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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