Fixed Dose Combination Therapy for Secondary Prevention of Major Cardiovascular Events: Review of Literature and Design for Persian Polypill, A Randomized Clinical Trial.

This is a review on clinical trials assessing polypill in secondary prevention of cardiovascular diseases (CVD), followed by design of Persian Polypill study. We identified six completed studies and three ongoing trials having at least 10% of their participants with established CVD. Evaluation of these trials showed insufficient data to support polypill as a strategy to reduce major adverse cardiovascular events (MACE) in CVD patients, and a lack of studies in low and middle income countries.

Effect of melatonin on heart failure: design for a double-blinded randomized clinical trial.

Aims: Current studies indicate that melatonin can counteract renin-angiotensin-aldosterone system and sympathetic over activity in heart failure (HF) and might have a protective and repairing effect on cardiovascular injuries, skeletal muscle weakness, and metabolic abnormalities, which are common pathological processes in patients with HF. The MeHR trial (Melatonin for Heart Failure with Reduced Ejection Fraction) aims to evaluate the effect of oral melatonin on myocardial, skeletal muscle, and metabolic dysfunctions in HF, which leads to lower quality of life and increased morbidity and mortality in these patients.

Methods And Results: This is a double-blind randomized clinical trial with two parallel arms of 1:1 allocation, which recruits 90 outpatients with HF with reduced ejection fraction.