Clinical trial NCT04252287: A Study on Impact of Canagliflozin on Health Status, Quality of Life, and Functional Status in Heart Failure
Official title: Canagliflozin: Impact on Health Status, Quality of Life, and Functional Status in Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 476
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Total Daily Step Count at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in KCCQ Individual Domain Scores (Physical Limitation and Quality of Life) at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in KCCQ Clinical Summary Score at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in KCCQ Overall Summary Score at Week 12
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Mercy Clinic Cardiology - Fort Smith
state: Arkansas
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Clearwater
country: United States
facility: Clearwater Cardiovascular Consultants
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Boise
country: United States
facility: St Lukes Regional Medical
state: Idaho
city: Peoria
country: United States
facility: OSF HealthCare Cardiovascular Institute
state: Illinois
city: Winfield
country: United States
facility: Central Dupage Hospital
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Cancer Institute
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center Research Institute
state: Kansas
city: Hyattsville
country: United States
facility: MedStar Health Research Institute
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Kansas City
country: United States
facility: St. Luke's Hospital Kansas City
state: Missouri
city: Washington
country: United States
facility: Mercy Health Research
state: Missouri
city: Piscataway
country: United States
facility: Robert Wood Johnson Medical School Dept. of Medicine
state: New Jersey
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Corpus Christi
country: United States
facility: Thomas Spann Clinic
state: Texas
city: Houston
country: United States
facility: Texas Heart Institute
state: Texas
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.