Evaluation Effects of Coadministration of Empagliflozin and Colchicine on Quality of life in Heart Failure with Reduced Ejection Fraction: A Randomized Clinical Trial

Abstract

Background: Heart diseases are the first cause of death in the world. This study was designed to investigate the effect of colchicine and empagliflozin on the quality of life of heart failure patients; SGLT2-i, independent of its hypoglycemic activity, shows significant cardiac and renal benefits, and colchicine as an anti-inflammatory agent, because inflammatory factors increase in heart failure and have negative effects on the quality of life of these patients.Objective: Investigating the effects of empagliflozin and colchicine combination therapy on quality of life in heart failure patients with reduced ejection fraction.Methods: This study was conducted as a randomized, blinded and pilot clinical trial at Shahid Madani Heart Hospital in Tabriz. 50 heart failure patients who had almost the same disease conditions were randomly divided into two groups of 25 (control and intervention). The control group received standard treatment along with empagliflozin and the intervention group received colchicine and empagliflozin in addition to routine treatment. Then, the patients' quality of life was assessed using the KCCQ-12 questionnaire at baseline and at month one and three and analyzed in SPSS software.Methods: Results: In this study, the quality of life of the patients in the baseline and the first month was not significantly related to each other, but in the third month, the quality of life of the patients in the colchicine and empagliflozin group was significantly higher than the control group (P=0.02).Conclusion: This study showed that colchicine and empagliflozin combination therapy significantly improves the quality of life of patients. In these patients who were evaluated at baseline, the first month and the third month, we saw an increase in the quality of life in the intervention group based on the KCCQ-12 scale.