A Study on Impact of Canagliflozin on Health Status, Quality of Life, and Functional Status in Heart Failure
Completed · Phase 3 · Has a placebo group
Conditions studied: Heart Failure
In brief
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).
Key facts
- Study ID
- NCT04252287
- Run by
- Janssen Research & Development, LLC
- People needed
- 476
- Starts
- 2020-03-10
- Expected to finish
- 2021-11-09
- Last updated by the study team
- 2025-03-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mercy Clinic Cardiology - Fort Smith — Fort Smith, Arkansas, United States
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
- Clearwater Cardiovascular Consultants — Clearwater, Florida, United States
- Emory University — Atlanta, Georgia, United States
- St Lukes Regional Medical — Boise, Idaho, United States
- OSF HealthCare Cardiovascular Institute — Peoria, Illinois, United States
- Central Dupage Hospital — Winfield, Illinois, United States
- Parkview Cancer Institute — Fort Wayne, Indiana, United States
- University of Kansas Medical Center Research Institute — Kansas City, Kansas, United States
- MedStar Health Research Institute — Hyattsville, Maryland, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Henry Ford Hospital — Detroit, Michigan, United States
- St. Luke's Hospital Kansas City — Kansas City, Missouri, United States
- Mercy Health Research — Washington, Missouri, United States
- Robert Wood Johnson Medical School Dept. of Medicine — Piscataway, New Jersey, United States
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
- Thomas Spann Clinic — Corpus Christi, Texas, United States
- Texas Heart Institute — Houston, Texas, United States
Full record on ClinicalTrials.gov
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