Effect of N-acetylcysteine as adjunct therapy versus placebo on clinical outcomes and serum levels of oxidative stress biomarkers in patients with systolic heart failure: a double blind clinical trial

To assess the effect of N-acetylcysteine as adjunct therapy versus placebo on clinical outcomes and serum levels of oxidative stress biomarkers in patients with systolic heart failure

This is a double-blind randomized clinical trial, phase II, in which 80 eligible patients will be randomly assigned to the intervention and control groups

The eligible patients with systolic heart failure will refer to Farshchian Heart Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded so that neither patients nor the physician will examine the patients will be aware of the intervention.

Inclusion criteria: Age of 18 to 80 years, Systolic heart failure, Constant drug treatment for heart failure for at least 2 months, Stable clinical and hemodynamic status, Exclusion criteria: Pregnancy or breastfeeding, Concomitant chronic liver, kidney or respiratory diseases, History of myocardial infarction

Intervention group: Routine treatment plus adjunct therapy with N-acetylcysteine tablet 600 mg (manufactured by Hakim Pharmaceutical Company) every 12 hours for 3 months Control group: Routine treatment plus adjunct therapy with placebo (manufactured by Hakim Pharmaceutical Company) every 12 hours for 3 months

Left and right ventricular ejection fraction, left and right ventricular Tei-index, left and right ventricular strain, the activity of catalase enzyme, the activity of superoxide dismutase enzyme, the activity of peroxidase enzyme, the activity of malondialdehyde enzyme, the activity of total antioxidant capacity

The patients will be randomly assigned to intervention and control groups. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.

The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as triple-blind