Heart Failure Clinical Trial
A Study on Impact of Canagliflozin on Health Status, Quality of Life, and Functional Status in Heart Failure
Summary
The purpose of this study is to determine the superiority of the effectiveness of canagliflozin 100 milligram (mg) daily versus placebo in participants with symptomatic heart failure (HF) in improving the overall Kansas City Cardiomyopathy Questionnaire (KCCQ) Total Symptom Score (TSS).
Eligibility Criteria
Inclusion Criteria:
- Have clinically stable symptomatic heart failure (HF) (heart failure with reduced ejection fraction [HFrEF] and heart failure with preserved ejection fraction [HFpEF]): (A) For HFrEF: (a) ejection fraction (EF) less than or equal to (<=) 40 percent (%) and (b) a primary diagnosis of HF OR 2 medical visits (including virtual) with a HF diagnosis code in any position in the past 18 months (B) For HFpEF: (a) EF greater than (>) 40%; (b) a primary diagnosis of HF OR 2 medical visits (including virtual) with a HF diagnosis code in any position in the past 18 months, AND; (C) on a loop diuretic or spironolactone or eplerenone (mineralocorticoid receptor antagonists), in the past 18 months
Have a baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) score of less than or equal to (<=) 80 prior to randomization
Be able to read and understand English
Possess and have sole use (example: not shared with other users) of smartphone compatible with the Fitbit device
Willing/able to wear the Fitbit device on a regular basis for the 9-month study period
Exclusion Criteria:
Currently taking a sodium-glucose co-transporter 2 inhibitor (SGLT2i) or within the last 3 months
History of diabetic ketoacidosis or have type 1 diabetes mellitus (T1DM)
Have acute decompensated HF (exacerbation of symptomatic HF) requiring intravenous diuretics, inotropes, or vasodilators within the last 4 weeks
Have stage 4 or 5 Chronic Kidney Disease (that is, estimated glomerular filtration rate [eGFR] <30 milliliter per minute [ml/min] on dialysis) from the most recent assessment
Have a diagnosis of hypotension within 30 days
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There are 18 Locations for this study
Fort Smith Arkansas, 72903, United States
Aurora Colorado, 80045, United States
Clearwater Florida, 33756, United States
Atlanta Georgia, 30022, United States
Boise Idaho, 83712, United States
Peoria Illinois, 61614, United States
Winfield Illinois, 60190, United States
Fort Wayne Indiana, 46845, United States
Kansas City Kansas, 66160, United States
Hyattsville Maryland, 20782, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48202, United States
Kansas City Missouri, 64111, United States
Washington Missouri, 63090, United States
Piscataway New Jersey, 08854, United States
Cleveland Ohio, 44106, United States
Corpus Christi Texas, 78412, United States
Houston Texas, 30322, United States
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