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

Phase 3

Completed

• Conditions: Heart Failure
• Interventions: Drug: Canagliflozin 100 mg; Drug: Placebo

• Registration Number: NCT04252287
• Lead Sponsor: Janssen Research & Development, LLC

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-31
• Study First Submitted QC: 2020-01-31
• Study First Posted: 2020-02-05
• Study Start: 2020-03-10
• Primary Completion: 2021-11-09
• Study Completion: 2021-11-09
• Results First Submitted: 2022-11-07
• Status Verified: 2022-12
• Results First Submitted QC: 2022-12-20
• Last Update Submitted: 2022-12-20
• Results First Posted: 2023-01-12
• Last Update Posted: 2023-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 476

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Canagliflozin 100 mg	Canagliflozin 100 mg	Participants will be administered 100 milligram (mg) immediate-release, over-encapsulated tablets (as a capsule) orally once daily for 12 weeks.
Placebo	Placebo	Participants will be administered matching placebo capsules orally once daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 12	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 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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Total Daily Step Count at Week 12	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.
Change From Baseline in KCCQ Individual Domain Scores (Physical Limitation and Quality of Life) at Week 12	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 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.
Change From Baseline in KCCQ Overall Summary Score at Week 12	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 100, with 0 denoting the worst and 100 the best possible status. KCCQ- overall summary score was average of domains- physical limitation, total symptoms (average of symptom frequency and symptom burden), quality of life, and social limitation, and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status.
Change From Baseline in KCCQ Clinical Summary Score at Week 12	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 100, with 0 denoting the worst and 100 the best possible status. KCCQ-clinical summary score was average of domains- physical limitation and total symptoms (average of symptom frequency and symptom burden), and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status.

Trial Locations

Locations (18)

University of Colorado - Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States

OSF HealthCare Cardiovascular Institute; 🇺🇸 Peoria, Illinois, United States

Central Dupage Hospital; 🇺🇸 Winfield, Illinois, United States

University of Kansas Medical Center Research Institute; 🇺🇸 Kansas City, Kansas, United States

MedStar Health Research Institute; 🇺🇸 Hyattsville, Maryland, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Mercy Health Research; 🇺🇸 Washington, Missouri, United States

Robert Wood Johnson Medical School Dept. of Medicine; 🇺🇸 Piscataway, New Jersey, United States

Clearwater Cardiovascular Consultants; 🇺🇸 Clearwater, Florida, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Parkview Cancer Institute; 🇺🇸 Fort Wayne, Indiana, United States

Thomas Spann Clinic; 🇺🇸 Corpus Christi, Texas, United States

Texas Heart Institute; 🇺🇸 Houston, Texas, United States

Mercy Clinic Cardiology - Fort Smith; 🇺🇸 Fort Smith, Arkansas, United States

St Lukes Regional Medical; 🇺🇸 Boise, Idaho, United States

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

St. Luke's Hospital Kansas City; 🇺🇸 Kansas City, Missouri, United States