A Study on Impact of Canagliflozin on Health Status, Quality of Life, and Functional Status in Heart Failure
NCT ID: NCT04252287
Last Updated: 2025-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
476 participants
INTERVENTIONAL
2020-03-10
2021-11-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Canagliflozin 100 mg
Participants will be administered 100 milligram (mg) immediate-release, over-encapsulated tablets (as a capsule) orally once daily for 12 weeks.
Canagliflozin 100 mg
Participants will receive 100 mg immediate-release, over-encapsulated tablets (as a capsule) orally once daily.
Placebo
Participants will be administered matching placebo capsules orally once daily for 12 weeks.
Placebo
Participants will receive matching placebo capsules orally once daily.
Interventions
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Canagliflozin 100 mg
Participants will receive 100 mg immediate-release, over-encapsulated tablets (as a capsule) orally once daily.
Placebo
Participants will receive matching placebo capsules orally once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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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
Countries
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References
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Mohebi R, Jones PG, Spertus JA, Lingvay I, Lanfear DE, Gosch KL, Birmingham M, Kosiborod MN, Butler J, Januzzi JL Jr. Early Longitudinal Change in Heart Failure Health Status Following Initiation of Canagliflozin. JACC Heart Fail. 2024 Apr;12(4):711-718. doi: 10.1016/j.jchf.2024.01.005. Epub 2024 Feb 21.
Golbus JR, Gosch K, Birmingham MC, Butler J, Lingvay I, Lanfear DE, Abbate A, Kosiborod ML, Damaraju CV, Januzzi JL Jr, Spertus J, Nallamothu BK. Association Between Wearable Device Measured Activity and Patient-Reported Outcomes for Heart Failure. JACC Heart Fail. 2023 Nov;11(11):1521-1530. doi: 10.1016/j.jchf.2023.05.033. Epub 2023 Jul 26.
Nassif M, Birmingham MC, Lanfear DE, Golbus JR, Gupta B, Fawcett C, Harrison MC, Spertus JA. Recruitment Strategies of a Decentralized Randomized Placebo Controlled Clinical Trial: The Canagliflozin Impact on Health Status, Quality of Life and Functional Status in Heart Failure (CHIEF-HF) Trial. J Card Fail. 2023 Jun;29(6):863-869. doi: 10.1016/j.cardfail.2023.04.001. Epub 2023 Apr 10.
Spertus JA, Birmingham MC, Nassif M, Damaraju CV, Abbate A, Butler J, Lanfear DE, Lingvay I, Kosiborod MN, Januzzi JL. The SGLT2 inhibitor canagliflozin in heart failure: the CHIEF-HF remote, patient-centered randomized trial. Nat Med. 2022 Apr;28(4):809-813. doi: 10.1038/s41591-022-01703-8. Epub 2022 Feb 28.
Spertus JA, Birmingham MC, Butler J, Lingvay I, Lanfear DE, Abbate A, Kosiborod ML, Fawcett C, Burton P, Damaraju CV, Januzzi JL, Whang J. Novel Trial Design: CHIEF-HF. Circ Heart Fail. 2021 Mar;14(3):e007767. doi: 10.1161/CIRCHEARTFAILURE.120.007767. Epub 2021 Mar 16.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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28431754HFA3002
Identifier Type: OTHER
Identifier Source: secondary_id
CR108750
Identifier Type: -
Identifier Source: org_study_id
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