18 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 12Primary· Baseline, Week 12
Change from baseline in KCCQ-TSS was reported. KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denotin
Group
Value
95% CI
Placebo
4.9
± 1.27
Canagliflozin 100 mg
9.2
± 1.27
Change From Baseline in Total Daily Step Count at Week 12Secondary· Baseline, Week 12
Change from baseline in total daily step count at Week 12 was reported in this outcome measure. The number of steps taken per day was measured using a step activity monitor at baseline and throughout the study. Step count was measured from the Fitbit device data. The Fitbit app on the participant's phone collected all data from the Fitbit device. A negative change from baseline indicated a decrease in the number of daily steps.
Group
Value
95% CI
Placebo
-74.9
± 112.85
Canagliflozin 100 mg
-45.1
± 113.78
Change From Baseline in KCCQ Individual Domain Scores (Physical Limitation and Quality of Life) at Week 12Secondary· Baseline, Week 12
Change from baseline in KCCQ physical limitation score and KCCQ quality of life score were reported. KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated fo
KCCQ-Physical Limitation
Group
Value
95% CI
Placebo
4.8
± 1.26
Canagliflozin 100 mg
7.8
± 1.27
KCCQ-Quality of Life
Group
Value
95% CI
Placebo
9.1
± 1.40
Canagliflozin 100 mg
12.4
± 1.41
Change From Baseline in KCCQ Clinical Summary Score at Week 12Secondary· Baseline, Week 12
Change from baseline in KCCQ-clinical summary score was reported. KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to
Group
Value
95% CI
Placebo
4.7
± 1.16
Canagliflozin 100 mg
8.5
± 1.17
Change From Baseline in KCCQ Overall Summary Score at Week 12Secondary· Baseline, Week 12
Change from baseline in KCCQ-overall summary score was reported. KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 1
Group
Value
95% CI
Placebo
6.2
± 1.18
Canagliflozin 100 mg
9.5
± 1.18
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03170518 — A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Typ
· Phase 3
· completed
NCT01809327 — A Study to Evaluate the Effectiveness, Safety, and Tolerability of Canagliflozin in Combination With Metformin in the Tr
· Phase 3
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Janssen Research & Development, LLC
Last refreshed: 30 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04252287.