A Study on Impact of Canagliflozin on Health Status, Quality of Life, and Functional Status in Heart Failure

Janssen Research & Development, LLC476 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

476

Conditions

Heart Failure

Interventions

Canagliflozin 100 mgDRUG

Participants will receive 100 mg immediate-release, over-encapsulated tablets (as a capsule) orally once daily.

PlaceboDRUG

Participants will receive matching placebo capsules orally once daily.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (18)

Mercy Clinic Cardiology - Fort Smith

Fort Smith, Arkansas, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at 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 denoting the worst and 100 the best possible status. KCCQ-TSS was average of domains- symptom frequency and symptom burden, and transformed to a single score which ranged from 0 (worst) to 100 (the best possible status), where the higher score reflected better health status.

Time frame: Baseline, Week 12

Secondary Outcomes

Change From Baseline in Total Daily Step Count at 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.

Time frame: Baseline, Week 12

Change From Baseline in KCCQ Individual Domain Scores (Physical Limitation and Quality of Life) at 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 for each domain and scaled from 0 to 100, with 0 (worst) and 100 (the best possible status), where the higher score reflected better health status.

Data from ClinicalTrials.gov

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