A Study on Impact of Canagliflozin on Health Status, Quality of Life, and Functional Status in Heart Failure (CHIEF-HF)

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 3

Conditions: Heart Failure

Treatments: Drug: Placebo; Drug: Canagliflozin 100 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04252287

CR108750

28431754HFA3002 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 476 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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476 participants in 2 patient groups, including a placebo group

Canagliflozin 100 mg

Experimental group

Description:

Participants will be administered 100 milligram (mg) immediate-release, over-encapsulated tablets (as a capsule) orally once daily for 12 weeks.

Treatment:

Drug: Canagliflozin 100 mg

Placebo

Placebo Comparator group

Description:

Participants will be administered matching placebo capsules orally once daily for 12 weeks.

Treatment:

Drug: Placebo