Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000337370
Ethics application status
Approved
Date submitted
11/07/2008
Date registered
17/07/2008
Date last updated
17/07/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Landmark Study III - A randomised controlled trial comparing the impact of aggressive risk factor and lifestyle modification utilising nurse led co-ordinated care with standard care to limit the progression of cardiovascular disease in patients with chronic kidney disease.
Scientific title
Landmark Study III - A randomised controlled trial comparing the impact of aggressive risk factor and lifestyle modification utilising nurse led co-ordinated care with standard care to limit the progression of cardiovascular disease in patients with chronic kidney disease.
Universal Trial Number (UTN)
Trial acronym
Landmark III
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 3400 0
Condition category
Condition code
Renal and Urogenital 3545 3545 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aggressive cardivascular risk factor and lifestyle modification utilising nurse led co-ordinated care. The trial clinic will be additional to the patients' usual medical care. The trial clinic will use a co-ordinated care approach to achieving cardiovascular risk factor modification and include a significant lifestyle and diet modification component customized to the patients' health care needs. There will be focus on patient self-management and motivation for sustainable behavior change. Patients will be followed for up to 3 years. For patients in the Nurse coordinated care arm, they will be seen for an initial assessment (approximately 1 hour) about 2 weeks after enrollment. Then out to monthly or further apart follow up (half hour session) depending on their needs and stage of chronic kidney disease (CKD). These visits with the nurses alternate with visits to Nephrology outpatients department (shared care). This for the duration of the trial which is 3 years.
Intervention code [1] 3124 0
Lifestyle
Comparator / control treatment
Standard care with Nephrologist in renal outpatients at Princess Alexandra Hospital. Standard care is the Outpatient visits to nephrology and necessary referrals where needed. Standard care patients will be followed for 3 years.
Control group
Active

Outcomes
Primary outcome [1] 4447 0
Carotid intima media thickness (ultrasound of vascular structure)
Timepoint [1] 4447 0
At baseline 12 months, 24 months and 36 months
Secondary outcome [1] 7519 0
Exercise stress echocardiography (development of new areas of poor heart blood flow)
Timepoint [1] 7519 0
At baseline 12 months, 24 months and 36 months
Secondary outcome [2] 7561 0
Brachial Artery Reactivity (ultrasound of vascular function)
Timepoint [2] 7561 0
At baseline 12 months, 24 months and 36 months

Eligibility
Key inclusion criteria
Patients with stage 3 or 4 chronic kidney disease (eGFR - estimated Glomerular Filtration Rate <60ml/min and >25 ml/min); Must have one of the following risk factors – Blood pressure not at target; Overweight (BMI - Body Mass Index >25) ; Poor diabetic control; or Lipids not at target
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients from areas in Queensland where follow-up vascular studies can not be carried out for logistic reasons; Unable or unwilling to give informed consent; estimated Glomerular Filtration Rate (eGFR) < 25ml/min; Pregnant; Life expectancy less than 6 months; Current involvement in other research study; Organ transplant

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/03/2008
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)

Funding & Sponsors
Funding source category [1] 3583 0
Government body
Name [1] 3583 0
National Health and Medical Research Council (NHMRC) (CCRE - Centres of Clinical Research Excellence)
Country [1] 3583 0
Australia
Primary sponsor type
University
Name
CCRE - Centres of Clinical Research Excellence
Address
The University of Queensland
Brisbane QLD 4072 Australia
Country
Australia
Secondary sponsor category [1] 3219 0
Hospital
Name [1] 3219 0
Princess Alexandra Hospital, Nephrology Department
Address [1] 3219 0
Ipswich Road, Woolloongabba Qld 4102
Country [1] 3219 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5629 0
Princess Alexandra Hospital
Ethics committee address [1] 5629 0
Ethics committee country [1] 5629 0
Australia
Date submitted for ethics approval [1] 5629 0
Approval date [1] 5629 0
Ethics approval number [1] 5629 0
2007/190

Summary
Brief summary
Chronic kidney disease (CKD) is associated with a twenty-fold increase in the death from heart and blood vessel disease (cardiovascular disease -CVD). Patients with CKD have multiple risk factors for CVD and
include high cholesterol, hypertension, anaemia, abnormalities of blood chemistry, diabetes, obesity and sedentary lifestyle. Intervention may decrease the progression of CVD and treatment guidelines have been
developed. However, patients with CKD have complex health issues and audit data suggests that within the current model of care, many do not reach treatment targets.
Co-ordinated care clinics utilizing a nurse led, case management approach and a multidisciplinary team have been demonstrated to optimize CKD care and decrease progression of kidney dysfunction. However, the impact on progression of CVD has not been studied.
The hypothesis of this proposal is therefore:
Nurse led co-ordinated care approach to cardiovascular risk factor and lifestyle modification will reduce the progression of CVD when compared with standard care, in patients with CKD. Additional hypotheses are: The nurse led clinic improves service quality and patient satisfaction AND This model of care will be cost effective.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28742 0
Address 28742 0
Country 28742 0
Phone 28742 0
Fax 28742 0
Email 28742 0
Contact person for public queries
Name 11899 0
Dr Nicole Isbel
Address 11899 0
Nephrology department, Princess Alexandra Hospital, Ipswich Road, Woolloongabba Qld 4102
Country 11899 0
Australia
Phone 11899 0
07 3240 5080
Fax 11899 0
07 3240 5480
Email 11899 0
[email protected]
Contact person for scientific queries
Name 2827 0
Dr Nicole Isbel
Address 2827 0
Nephrology department, Princess Alexandra Hospital, Ipswich Road, Woolloongabba Qld 4102
Country 2827 0
Australia
Phone 2827 0
07 3240 5080
Fax 2827 0
07 3240 5480
Email 2827 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
SourceTitleYear of PublicationDOI
EmbaseEffect of a 3-Year Lifestyle Intervention in Patients with Chronic Kidney Disease: A Randomized Clinical Trial.2022https://dx.doi.org/10.1681/ASN.2021050668
EmbaseLeft ventricular global longitudinal strain is associated with cardiovascular risk factors and arterial stiffness in chronic kidney disease.2015https://dx.doi.org/10.1186/s12882-015-0098-1
EmbaseAgreement between cystatin-C and creatinine based eGFR estimates after a 12-month exercise intervention in patients with chronic kidney disease.2018https://dx.doi.org/10.1186/s12882-018-1146-4
EmbaseOxidative stress is associated with decreased heart rate variability in patients with chronic kidney disease.2017https://dx.doi.org/10.1080/13510002.2016.1173326
Dimensions AIMultimodality vascular imaging in CKD: divergence of risk between measured parameters2011https://doi.org/10.1093/ndt/gfr397
N.B. These documents automatically identified may not have been verified by the study sponsor.