The effect of lower salt exposure at haemodialysis on cardiac micro-injury, in home and self-care haemodialysis patients.

Phase 3

Recruiting

• Conditions: Cardiovascular outcomes; End-Stage Kidney Disease; Renal and Urogenital - Kidney disease; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12614000070639
• Lead Sponsor: The Centre for Clinical Research and effective practice (CCRep), registered with the New Zealand Charities Commission (ref# CC21537)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

1. Incident or prevalent patients treated with maintenance home or self-care 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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is High-Sensitivity Troponin (hsTnT).<br>hsTnT assay will be performed on frozen serum samples which are being drawn immeadiately prior to haemodialysis after a long break.[0,3,6,9,12 months.]

Secondary Outcome Measures

Name	Time	Method
Segmental Wall Motion Index (SWMI) measured on cardiac MRIs performed prior to haemodialysis treatments and after a long break.[0 and 12 months]