Dapagliflozin’s impact on health-related quality of life and mortality in patients of chronic heart failure with reduced ejection fraction: a randomized controlled trial

Abstract

Objective: To explore the impact of dapagliflozin on health-related quality of life, functional status and mortality in chronic heart failure with reduced ejection fraction patients.

Method: The randomized controlled trial was conducted from April 2023 to May 2024 at the Department of Pharmacology and Therapeutics, Army Medical College, National University of Medical Sciences, Islamabad, Pakistan, in collaboration with the National Institute of Heart Diseases, Rawalpindi, and the Pakistan Ordinance Factories Hospital, Wah Cantt, and comprised chronic heart failure with reduced ejection fraction patients who were randomised into two equal groups, with control group A receiving conventional therapy alone, and intervention group B receiving oral dapagliflozin 10mg daily in addition to the conventional therapy. At 3-month follow-up, each patient was subjected to Kansas City Cardiomyopathy Questionnaire for health-related quality of life, the New York Heart Association classification for functional status, and mortality check. Data was analysed using SPSS 31.

Results: Of the 170 patients, 136(80%) were male and 34(20%) were female. There were 85(50%) patients in group A with mean age 64.71±10.07 years and 85(50%) in group B with mean age 62.67± 9.75 years. Both the groups showed improvement post-intervention, but group B had significantly more improvement in quality of life (p=0.048) and overall summary scores (p=0.037). Functional status was better in group B, but the difference was non-significant (p=0.320). The trial was completed by 83(98%) patients in group B and 80 (94%) in group A. Mortality was lower in group B 2(2.4%) than in group A 5(5.9%).

Conclusion: Dapagliflozin led to marked improvement in health-related quality of life and reduced mortality in chronic heart failure with reduced ejection fraction patients.

Trial Registration: The trial was registered with the Iranian clinical trial registry under registration number IRCT20230331057788N1 at 2023-04-04.

Key Words: Dapagliflozin, Health-related quality of life, Kansas City Cardiomyopathy Questionnaire, New York Heart Association.