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28431754HFA3002 Canagliflozin: Impact on Health Status, Quality of Life, and Functional Status in Heart Failure (CHIEF - HF)

The primary objective is: * to determine the superiority of the effectiveness of canagliflozin 100 mg daily versus placebo in participants with symptomatic HF in improving the overall KCCQ TSS. The first key secondary objective is: * to determine the superiority of the effectiveness of canagliflozin 100 mg daily versus placebo in improving the total daily step count. The second key secondary objective is: * to determine the superiority of the effectiveness of canagliflozin 100 mg daily versus placebo in improving the KCCQ individual domain scores (physical limitation, quality of life, clinical summary, and overall). The exploratory objectives are to assess the effectiveness of canagliflozin 100 mg daily in participants with symptomatic HF by: * responses on the Patient Global Impression of Change (PGIC) and the Patient Global Impression of Severity (PGI-S) * healthcare resource utilization (HRU) and health economics data * associations (correlations and/or categorical association measures) between digital markers (step count and floors climbed), and clinical events such as need for outpatient intravenous therapies, emergency department (ED) visits, and hospitalizations * daily floors climbed * time to first hospitalization/readmission for heart failure * time to first hospitalization/readmission for other events * time to death * the participant s satisfaction with their experience with the virtual design at the end of the study.

Phase

IIIb

Recruitment Status

Past Studies