Trial from ANZCTR


Trial ID ACTRN12611000975998
Trial Status: Registered
Date Submitted: 10/09/2011
Date Registered: 13/09/2011
Prospectively registered

Page 1

Public title The effect of lower salt exposure on the cardiac structure and function of patients on home haemodialysis
Update:
 
Reason:
 
Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format A randomised, controlled trial of low sodium dialysate versus conventional sodium dialysate to reduce left ventricular mass index in patients receiving home haemodialysis
Update:
 
Reason:
 
Secondary ID [1] 263020 0
Health Research Council (HRC) of New Zealand 11-583
Update:
 
Reason:
 
Secondary ID [2] 263021 0
New Zealand Health and Disability Multi-region Ethics Committee MEC/11/09/081
Update:
 
Reason:
 
UTN U1111-1124-4705
Update:
 
Reason:
 
Trial acronym The SOdium Lowering In Dialysate (SOLID) Trial
Update:
 

Page 2

Health condition(s) or problem(s) studied:
Cardiovascular outcomes in dialysis patients 270746 0
 Update:
 Reason:
Condition category: Condition code:
Cardiovascular Other cardiovascular diseases
 Update:
 Update:
  Reason:
270924 270924 0 0
Renal and Urogenital Kidney disease
 Update:
 Update:
  Reason:
270943 270943 0 0

Page 3

Descriptions of intervention(s) / exposure Low dialysate [Na+] at 135mM up to (and including) 3.5 times per week at every haemodialysis treatment for 12 months
Update:
 
Reason:
 
Intervention Code:
Treatment: Devices 269362 0
Update:
 
Reason:
 
Intervention Code:
Treatment: drugs 269377 0
Update:
 
Reason:
 
Intervention Code:
Prevention 269378 0
Update:
 
Reason:
 
Comparator / control treatment Standard dialysate [Na+] at 140mM up to (and including) 3.5 times per week at every haemodialysis treatment for 12 months
Update:
 
Reason:
 
Control group Dose comparison
Update:
 
Reason:
 

Page 4

Primary Outcome: Left ventricular mass index (left ventricular mass / body surface area), as measured using cardiac MRI 279591 0
Update:
 
Reason:
 
Timepoint: At baseline and 12 months after randomization 279591 0
Update:
 
Reason:
 
Secondary Outcome: Left ventricular volumes, as measured using cardiac MRI 287992 0
Update:
 
Reason:
 
Timepoint: At baseline and 12 months after randomization 287992 0
Update:
 
Reason:
 
Secondary Outcome: Left ventricular haemodynamics, as assessed by NT-pro-BNP and Urotensin II levels 287993 0
Update:
 
Reason:
 
Timepoint: At baseline, 3, 6, 9, and 12 months after randomization 287993 0
Update:
 
Reason:
 
Secondary Outcome: Extracellular fluid volume, as measured using bioimpedance spectroscopy 287994 0
Update:
 
Reason:
 
Timepoint: At baseline, 3, 6, 9, and 12 months after randomization 287994 0
Update:
 
Reason:
 
Secondary Outcome: Intra-dialytic BP measured as the median BP obtained during a midweek HD treatment 287995 0
Update:
 
Reason:
 
Timepoint: At baseline, 3, 6, 9, and 12 months after randomization 287995 0
Update:
 
Reason:
 
Secondary Outcome: Inter-dialytic BP measured as ambulatory recordings during a "long break" 287996 0
Update:
 
Reason:
 
Timepoint: At baseline, 6, and 12 months after randomization 287996 0
Update:
 
Reason:
 
Secondary Outcome: Inter-dialytic weight gain (pre-dialysis weight minus post-dialysis weight) 287997 0
Update:
 
Reason:
 
Timepoint: At baseline, 3, 6, 9, and 12 months after randomization 287997 0
Update:
 
Reason:
 
Secondary Outcome: Thirst and xerostomia, as measured using the Dialysis Thirst Inventory and Short Xerostomia Inventory 287998 0
Update:
 
Reason:
 
Timepoint: At baseline, 3, 6, 9, and 12 months after randomization 287998 0
Update:
 
Reason:
 
Secondary Outcome: Long-term cardiovascular mortality risk, as assessed by hsCRP levels 287999 0
Update:
 
Reason:
 
Timepoint: At baseline, 3, 6, 9, and 12 months after randomization 287999 0
Update:
 
Reason:
 
Secondary Outcome: Arterial compliance, as assessed by pulse wave velocity 288000 0
Update:
 
Reason:
 
Timepoint: At baseline, 3, 6, 9, and 12 months after randomization 288000 0
Update:
 
Reason:
 
Secondary Outcome: Pre- and post- dialysis plasma Na+ ionic activity, as measured using direct ionometry 288001 0
Update:
 
Reason:
 
Timepoint: At baseline, 3, 6, 9, and 12 months after randomization 288001 0
Update:
 
Reason:
 
Secondary Outcome: Tolerance to dialysis as assessed by the frequency of intra-dialytic hypotension and requirement for fluid boluses 288002 0
Update:
 
Reason:
 
Timepoint: At baseline, 3, 6, 9, and 12 months after randomization 288002 0
Update:
 
Reason:
 
Secondary Outcome: Health-related quality of life, as measured using the KDQOL and the EuroQol EQ-5D questionnaires 288003 0
Update:
 
Reason:
 
Timepoint: At baseline and 12 months after randomization 288003 0
Update:
 
Reason:
 
Secondary Outcome: Myocardial microinjury, as assessed by pre-dialysis levels of high sensitivity Troponin T levels 307751 0
Update:
 
Reason:
 
Timepoint: At baseline, 3, 6, 9, and 12 months after randomization 307751 0
Update:
 
Reason:
 
Secondary Outcome: Segmental left ventricular wall motion analysis using cardiac MRI according to a standard 17-segment score (each segment will be analysed individually and scored on the basis of motion and systolic thickening : normal or hyperdynamic - 1, hypokinetic – 2, akinetic -3, dyskinetic – 4, aneurysmal - 5. A segmental wall motion score index will be derived by dividing the sum of the wall motion scores by the number of segments visualised) 307752 0
Update:
 
Reason:
 
Timepoint: At baseline and 12 months 307752 0
Update:
 
Reason:
 
Secondary Outcome: Pattern of abnormal left ventricular remodeling using cardiac MRI: concentric hypertrophy, eccentric hypertrophy, and concentric remodeling as defined by absence or presence of left ventricular hypertrophy PLUS the absence or presence of an elevated left ventricular mass/left ventricular end-diastolic volume (M-C) ratio, with a partition value for elevated M-C ratio of 2.0
307753 0
Update:
 
Reason:
 
Timepoint: At baseline and 12 months 307753 0
Update:
 
Reason:
 

Page 5

Key inclusion criteria 1. Incident or prevalent patients treated with maintenance home haemodialysis or self care facility haemodialysis for end-stage kidney failure 2. Aged 18 years or older 3. Suitable for both low and standard dialysate [Na+] in the view of the treating physician 4. The person is willing to participate and has signed the Participant Information and Consent Form 5. Pre-dialysis plasma [Na+] > or = 135mM 6. The treating nephrologist agrees to the person’s participation in the SOLID trial
Update:
 
Reason:
 
Minimum age 18 Years
Update:
 
Reason:
 
Update:
 
Reason:
 
Maximum age No limit
Update:
 
Reason:
 
Update:
 
Reason:
 
Gender Both males and females
Update:
 
Reason:
 
Healthy volunteers? No
Update:
 
Reason:
 
Key exclusion criteria 1. Haemodialysis treatments at a frequency of greater than 3.5 times per week
2. Treatment with maintenance haemodiafiltration
3. Life expectancy of less than 12 months
4. Scheduled for live donor kidney transplantation within 12 months of entry to the study
5. Considered by the treating nephrologist to have concomitant illnesses or conditions that limit or contraindicate study procedures and followup (e.g. frequent intra-dialytic hypotension requiring fluid resuscitation)
6. Considered by the treating nephrologist to have a high chance of non-adherence to study treatments and non-attendance for procedures and follow-up
7. Current enrolment in clinical studies involving antihypertensive medications, changes in HD operating parameters, or any other intervention that is likely to confound the outcome of this trial
8. Documented obvious infiltrative cardiomyopathies (amyloid, glycogen storage disease), hereditary cardiomyopathies (hypertrophic cardiomyopathy), or moderate to severe aortic valve disease (aortic stenosis, regurgitation)
Update:
 
Reason:
 

Page 6

Study type Interventional
Update:
 
Reason:
 
Purpose of the study Prevention
Update:
 
Allocation to intervention Randomised controlled trial
Update:
 
Reason:
 
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Central randomisation by computer
Update:
 
Reason:
 
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) Permuted block randomization by computer software, stratified by (a) treating centre, and (b) conventional (=18 hours/week) versus extended-hour (>18 hours/week) HD.
Update:
 
Reason:
 
Masking / blinding Blinded (masking used)
Update:
 
Reason:
 
Who is / are masked / blinded (choose all that apply)


Update:
       
Reason:
 
Assignment Parallel
Update:
 
Reason:
 
Other design features
Update:
 
Reason:
 
Type of endpoint(s) Efficacy
Update:
 
Reason:
 
Statistical Methods/Analysis
Update:
 
Reason:
 

Page 7

Phase Phase 3
Update:
 
Reason:
 
Anticipated date of first participant enrolment 1/02/2012
Update:
 
Reason:
 
Date of first participant enrolment 26/03/2012
Update:
 
Reason:
 
Anticipated date last participant recruited/enrolled 31/07/2014
Update:
 
Reason:
 
Actual date last participant recruited/enrolled
Update:
 
Reason:
 
Target sample size 118
Update:
 
Reason:
 
Recruitment status Recruiting
Update:
 
Reason:
 
Update:
 
Reason:
 

Recruitment outside Australia

Country: New Zealand 3835 0
Update:
 
Reason:
 
State/Province: 3835 0
Update:
 
Reason:
 

Page 8

Funding Source: Government body 269822 0
Update:
 
Reason:
 
Name: Health Research Council (HRC) of New Zealand 269822 0
Update:
 
Reason:
 
Address: PO Box 5541, Wellesley Street, Auckland 1141 269822 0
Update:
 
Reason:
 
Country: New Zealand 269822 0
Update:
 
Reason:
 
Funding Source: Charities/Societies/Foundations 269823 0
Update:
 
Reason:
 
Name: The Maurice and Phyllis Paykel Trust 269823 0
Update:
 
Reason:
 
Address: PO Box 37760, Parnell, Auckland 1151 269823 0
Update:
 
Reason:
 
Country: New Zealand 269823 0
Update:
 
Reason:
 
Funding Source: Charities/Societies/Foundations 289070 0
Update:
 
Reason:
 
Name: Royal Australasian College of Physicians 289070 0
Update:
 
Reason:
 
Address: 145 Macquarie St, Sydney NSW 2000, Australia
289070 0
Update:
 
Reason:
 
Country: Australia 289070 0
Update:
 
Reason:
 
Primary Sponsor Charities/Societies/Foundations
Update:
 
Reason:
 
Name: The Centre for Clinical Research and effective practice (CCRep), registered with the New Zealand Charities Commission (ref# CC21537)
Update:
 
Reason:
 
Address: Middlemore Hospital, Private Bag 93311, Otahuhu, Auckland 1640
Update:
 
Reason:
 
Country: New Zealand
Update:
 
Reason:
 
Secondary Sponsor: None 268855 0
Update:
 
Reason:
 
Name: 268855 0
Update:
 
Reason:
 
Address: 268855 0
Update:
 
Reason:
 
Country: 268855 0
Update:
 
Reason:
 

Page 9

Has the study received approval from at least one Ethics Committee? Yes
Update:
 
Reason:
 
Ethics Committee name: New Zealand Health and Disabililty Multi-region Ethics Committee 271789 0
Update:
 
Reason:
 
Address: PO Box 5013, Lambton Quay, Wellington 6145 271789 0
Update:
 
Reason:
 
Country: New Zealand 271789 0
Update:
 
Reason:
 
Approval Date: 271789 0
Update:
 
Reason:
 
Submitted Date: 02/09/2011 271789 0
Update:
 
Reason:
 
HREC: MEC/11/09/081 271789 0
Update:
 
Reason:
 
Brief summary Home haemodialysis is a common and relatively inexpensive form of dialysis in New Zealand that generally provides good quality of life. However, survival is still poor compared to the general population and 67% of patients die from cardiovascular disease. The SOLID Trial evaluates a cost-free intervention that would potentially improve these patients’ cardiovascular outcomes. The intervention involves reducing salt administration during routine dialysis. Earlier research in South Auckland showed that this simple measure reduces blood pressure. The SOLID Trial tests whether this measure also improves cardiac structure and function, since this would in turn reduce the risk of sudden cardiac death. If the intervention works, it would become the standard practice both locally and globally, and improve survival for all dialysis patients but especially those undergoing home HD. Remarkably, the intervention may be one of the few in medicine to provide health benefits at no added cost.
Update:
 
Reason:
 
Trial website http://www.solid.org.nz
Update:
 
Trial related presentations / publications
Update:
 
Public Notes
Update:
 
Attachments [1] 28 0
http://www.anzctr.org.au/AnzctrAttachments/343461-1471-2369-14-149.pdf http://www.anzctr.org.au/AnzctrAttachments/343461-1471-2369-14-149.pdf
Update:
 
Reason:
 

Page 10

Principal Investigator
Title: A/Prof
Update:
 
Reason:
 
33139 0
Name: Mark R Marshall
Update:
 
Reason:
 
33139 0
Address: Counties Manukau District Health Board, Private Bag 93311, Auckland 1640, New Zealand
Update:
 
Reason:
 
33139 0
Country: New Zealand
Update:
 
33139 0
Reason:
 
Tel: +64 21 461766
Update:
 
Reason:
 
33139 0
Fax:
Update:
 
Reason:
 
33139 0
Email: mrmarsh@woosh.co.nz
Update:
 
Reason:
 
33139 0
Contact person for public queries
Title: Mrs
Update:
 
Reason:
 
16386 0
Name: Brenda Luey
Update:
 
Reason:
 
16386 0
Address: Centre for Clinical Research and effective practice Middlemore Hospital Private Bag 93311, Auckland 1640
Update:
 
Reason:
 
16386 0
Country: New Zealand
Update:
 
16386 0
Reason:
 
Tel: +64 (21) 824982
Update:
 
Reason:
 
16386 0
Fax: +64 (9) 2503878
Update:
 
Reason:
 
16386 0
Email: Jenny.Han@ccrep.org.nz
Update:
 
Reason:
 
16386 0

Contact person for scientific queries
Title: A/Prof
Update:
 
Reason:
 
7314 0
Name: Mark R Marshall
Update:
 
Reason:
 
7314 0
Address: Department of Renal Medicine Counties Manukau District Health Board Private Bag 93311, Auckland 1640
Update:
 
Reason:
 
7314 0
Country: New Zealand
Update:
 
7314 0
Reason:
 
Tel: +64 (21) 461766
Update:
 
Reason:
 
7314 0
Fax:
Update:
 
Reason:
 
7314 0
Email: solid.leadinvestigator@gmail.com
Update:
 
Reason:
 
7314 0

Contact person responsible for updating information
Title:
Update:
 
Reason:
 
25458 0
Name: Dr Joanna L Dunlop
Update:
 
Reason:
 
25458 0
Address: Department of Renal Medicine Counties Manukau District Health Board Private Bag 93311, Auckland 1640
Update:
 
Reason:
 
25458 0
Country: New Zealand
Update:
 
25458 0
Reason:
 
Tel: +64 (21) 575251
Update:
 
Reason:
 
25458 0
Fax:
Update:
 
Reason:
 
25458 0
Email: solid.fellow@gmail.com
Update:
 
Reason:
 
25458 0
   

Addition Cancer fields
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason: