ANZCTR - Registration

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Cardiovascular disease

Condition category

Condition code

Renal and Urogenital

Kidney disease

Cardiovascular

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]

Not applicable

Comparator / control treatment

N/A

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Mortality. Date of death and whether cardiovascular or non-cardiovascular cause will be requested from the ANZDATA database custodian.

Timepoint [1]

Ten years from study enrollment in the Landmark 1 trial

Primary outcome [2]

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]

Ten years from enrollment in original Landmark 1 trial

Secondary outcome [1]

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]

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?

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]

Princess Alexandra Hospital - Woolloongabba

Recruitment postcode(s) [1]

4102 - Woolloongabba

Funding & Sponsors

Funding source category [1]

University

Name [1]

Cardiovascular Imaging Research Centre, School of Medicine, University of Queensland

Address [1]

4th floor
Princess Alexandra Hospital
Ipswich Road
WOOLLOONGABBA QLD 4102

Country [1]

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]

Individual

Name [1]

Dr Nikky Isbel
Nephrology Department

Address [1]

Princess Alexandra Hospital
Ipswich Road
WOOLLOONGABBA QLD 4102

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro South Hospital and Health Service District HREC

Ethics committee address [1]

Princess Alexandra Hospital
Ipswich Road
WOOLLOONGABBA QLD 4102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

15/11/2012

Ethics approval number [1]

HREC/12/QPAH/459

Ethics committee name [2]

The University of Queensland Medical Research Ethics Committee

Ethics committee address [2]

The University of Queensland
Cumbrae-Stewart Building
Research Road
BRISBANE QLD 4072

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

13/12/2012

Ethics approval number [2]

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

A/Prof Tony Stanton

Address

UQ School of Medicine
4th floor
Princess Alexandra Hospital
Ipswich Road
WOOLLOONGABBA QLD 4102

Country

Australia

Phone

61 7 3176 5813

Fax

61 7 3176 5399

t.stanton@uq.edu.au

Contact person for public queries

Name

Julie Holliday

Address

UQ School of Medicine
4th floor
Princess Alexandra Hospital
Ipswich Road
WOOLLOONGABBA QLD 4102

Country

Australia

Phone

61 7 3176 6146

Fax

61 7 3176 5399

j.holliday@uq.edu.au

Contact person for scientific queries

Name

Tony Stanton

Address

UQ School of Medicine
4th floor
Princess Alexandra Hospital
Ipswich Road
WOOLLOONGABBA QLD 4102

Country

Australia

Phone

61 7 3176 5813

Fax

61 7 3176 5399

t.stanton@uq.edu.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.

Trial Review

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