Hypotheses, rationale, design, and methods for evaluation of a randomized controlled trial using Tocotrienol, an isomer of Vitamin E derived from palm oil, on the prevention of atrial fibrillation after coronary artery bypass grafting surgery

Abstract

Background: One of the most common complications following coronary artery bypass grafting (CABG) surgery is atrial fibrillation (AF), which contributes towards increasing morbidity and mortality, length of hospital stay (LoHS) and reduced quality of life (QoL) of patients. Objectives: To determine whether the intake of Tocotrienol, a Vitamin E isomer derived from palm oil, before and immediately following CABG prevents AF, reduces LoHS, and improves the QoL of patients. Protocol: The study is registered with the National Medical Research Register with a trial number NMRR-17-1994-34963 and designed as a prospective, randomized controlled trial (RCT) with parallel groups. The experimental group will receive two 200mg Tocotrienol capsules each day, while the control group will receive two identical placebo (palm Super Olein) capsules per day. ECG readings will be used to detect AF post operatively, LoHS will be measured by checking the records from the National Heart Institute Hospital register, and the health-related Quality of Life (HRQoL) analysis (the Malay version of the Short Form 36 Questionnaire) will be used to analyse QoL. The sample size was calculated to be 140 in each arm of the RCT for a power of 0.8 and a significance level of 0.05. Funding: HOVID Berhad funds this research project. Expected outcomes: The primary endpoint is the development of postoperative AF, whilst the secondary endpoints are the LoHS and HRQoL of patients post CABG. Future implications: Prevention of AF and its complications such as cardiovascular or cerebrovascular events, especially stroke, is an important output. Malaysia is one of the biggest producers and exporters of palm oil and palm oil products. Thus, the possibility of marketing Tocotrienol, in reducing AF post CABG surgery, is a very important proposition indeed. Trial number: NMRR-17-1994-34963