Protection Against Incidences of Serious Cardiovascular Events Study
Principal Investigators: Kevan Polkinghorne (Australia), Charmaine Lok (Canada)
Clinical Project Manager: Laura Robison (AKTN)
Clinical Research Associate: Ruth Stastny (AKTN)
Trial Number: AKTN 15.03
Population: End-Stage Kidney Disease (ESKD) patients on haemodialysis (HD)
Intervention: nK3 PUFA (fish oil) 4g/day or matched placebo
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 will be 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: Australian sites have reached the target of 200 participants and ceased recruitment.
Recruitment: 200 participants across Australia.
Cardiovascular disease (CVD) mortality is more than 40Kfold greater in end-stage kidney disease (ESKD) 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 test interventions targeted at the underlying mechanisms of CVD in ESKD 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 (RCT) to reduce CVD events in the general population and possibly in ESKD patients on maintenance haemodialysis (HD). However a well-designed, adequately powered randomised controlled trial has not been undertaken. HD patients have been found to have amongst the lowest recorded levels of nK3 PUFA. This proposal builds 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 ESKD patients on maintenance HD. This study will be the largest clinical study to definitively address whether supplementation with high dose n3KPUFA in adult HD ESKD patients will reduce rates of CVD events, CVD and all-cause mortality.