Phase 3
Completed N=476
A Study on Impact of Canagliflozin on Health Status, Quality of Life, and Functional Status in Heart Failure
Heart Failure
Source: ClinicalTrials.gov NCT04252287 ↗
Enrolled (actual)
476
Serious AEs
15.2%
Results posted
Jan 2023
Primary outcomePrimary: Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 12 — 4.9; 9.2 Score on a scale — p=0.016
◆ Published Evidence
Highly cited
235citations · ~59 / year
The SGLT2 inhibitor canagliflozin in heart failure: the CHIEF-HF remote, patient-centered randomized trial.
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).
Linked Publications (5)
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The SGLT2 inhibitor canagliflozin in heart failure: the CHIEF-HF remote, patient-centered randomized trial.
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Novel Trial Design: CHIEF-HF.
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Association Between Wearable Device Measured Activity and Patient-Reported Outcomes for Heart Failure.
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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.
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Early Longitudinal Change in Heart Failure Health Status Following Initiation of Canagliflozin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 12 |
4.9; 9.2 | 0.016 sig |
| SECONDARY Change From Baseline in Total Daily Step Count at Week 12 |
-74.9; -45.1 | 0.852 |
| SECONDARY Change From Baseline in KCCQ Individual Domain Scores (Physical Limitation and Quality of Life) at Week 12 |
4.8; 7.8; 9.1; 12.4 | — |
| SECONDARY Change From Baseline in KCCQ Clinical Summary Score at Week 12 |
4.7; 8.5 | — |
| SECONDARY Change From Baseline in KCCQ Overall Summary Score at Week 12 |
6.2; 9.5 | — |
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%; (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
Data sourced from ClinicalTrials.gov (NCT04252287) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.