Protection Against Incidences of Serious Cardiovascular Events Study
Principal Investigators: Kevan Polkinghorne (Australia), Charmaine Lok (Canada)
Clinical Project Manager: Pushparaj Velayudham (AKTN)
Clinical Research Associate: Ruth Campbell (AKTN)
Trial Number: AKTN 15.03
Population: Kidney failure patients on haemodialysis (HD)
Intervention: nK3 PUFA (fish oil) 4g/day or matched placebo
Recruitment start date: May 2018
Follow-up end date: April 2022
Primary outcome: The difference in the rate of serious cardiovascular (CV) events (i.e. number of events per unit time) between the two groups. A serious CV event is a composite of CV death and non-fatal CV events. CV death includes sudden cardiac death, fatal MI, or fatal stroke. Non-fatal CV events include non-fatal MI, non-fatal stroke, and PVD requiring amputation.
Status: Trial completed.
Recruitment: 200 participants across Australia.
Publication (1): The study results have now been published. Read the abstract via the link below (full article access is available only to journal subscribers): PubMed website
Trial Background
Cardiovascular disease (CVD) mortality is more than 40Kfold greater in kidney failure patients compared to the age-matched general population. Although there is an excess of traditional CVD risk factors, clinical trials targeting these risk factors have largely been negative. It is therefore crucial to test interventions targeted at the underlying mechanisms of CVD in kidney failure patients.
There has been considerable focus on novel CVD risk factors, including inflammation and oxidative stress. High-dose long-chain omegaK3 polyunsaturated essential fatty acids (nK3 PUFA) found in fish oil has been shown in randomised controlled trials (RCTs) to reduce CVD events in the general population and possibly in kidney failure patients on maintenance haemodialysis (HD). However, a well-designed, adequately powered RCT had not been previously undertaken. HD patients have been found to have amongst the lowest recorded levels of nK3 PUFA. This trial built on previous work by the investigator team to conduct a multicentre RCT evaluating the effects of high-dose nK3 PUFA supplementation on CVD events in kidney failure patients on maintenance HD. This study was the largest clinical study to definitively address whether supplementation with high dose n3KPUFA in adult HD kidney failure patients would reduce rates of CVD events, CVD and all-cause mortality.
Trial Summary
Conducted in twenty-six (26) centres across Australia and Canada, the trial recruited 1228 participants who were receiving haemodialysis treatment. 610 of these participants were randomised to take nK3 PUFA fish oil supplements while the remaining 618 were randomised to take a corn-oil placebo. All participants attended an initial study visit and were then followed up for 3.5 years.
It was found that those participants who took fish oil experienced 43% fewer serious cardiovascular events than those who took the placebo, suggesting that nK3 PUFA fish oil supplements may help prevent cardiovascular issues in people receiving haemodialysis treatment.
While this is a promising outcome, it is crucial that a kidney care doctor is consulted before patients make any changes to their medications and supplements.