A Prospective, Randomized, Double-blind, Multicenter Study on the Association Between Dapagliflozin-induced Improvement and Anemia in Heart Failure Patients (ADIDAS)

What this Trial Is About

Researchers are studying the changes in hemoglobin and how these changes relate to hospital readmissions due to heart failure and overall death in patients with heart failure. The study focuses on patients treated with either dapagliflozin or a placebo. This is a phase 4, interventional, double-blind, randomized trial conducted to explore whether correcting anemia is important for the benefits of dapagliflozin in heart failure patients. Participants will be assigned to receive either dapagliflozin 10 mg once daily along with standard heart failure treatments or a placebo with the same standard therapies. Standard treatments include medications like sacubitril/valsartan or ACE inhibitors/ARBs, beta-blockers, mineralocorticoid receptor antagonists, and may involve devices such as implantable cardioverter defibrillators and cardiac resynchronization therapy. The study will observe the impact of these treatments over follow-up periods of 3 months, 6 months, and 1 year. During the study, participants will have their hemoglobin levels, heart failure-related hospital admissions, and all-cause deaths monitored. Additional assessments include questionnaires on heart failure symptoms and quality of life, as well as a 6-minute walk test at baseline, 3 months, 6 months, and 1 year. The main outcome measured is the combined number of heart failure hospital admissions and deaths over one year, with continuous safety and health monitoring throughout the study.

Association Between Dapagliflozin-induced Improvement and Anemia in Heart Failure Patients (ADIDAS)