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

Heart Failure Clinical Trial

— CHIEF-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04252287
• Other study ID #: CR108750
• Secondary ID: 28431754HFA3002
• Status: Completed
• Phase: Phase 3
• Start date: March 10, 2020
• Est. completion date: November 9, 2021

Study information

• Verified date: December 2022
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 476
• Est. completion date: November 9, 2021
• Est. primary completion date: November 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Canagliflozin 100 mg
Participants will receive 100 mg immediate-release, over-encapsulated tablets (as a capsule) orally once daily.
• Placebo
Participants will receive matching placebo capsules orally once daily.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	University of Colorado - Anschutz Medical Campus	Aurora	Colorado
United States	St Lukes Regional Medical	Boise	Idaho
United States	Clearwater Cardiovascular Consultants	Clearwater	Florida
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Thomas Spann Clinic	Corpus Christi	Texas
United States	Henry Ford Hospital	Detroit	Michigan
United States	Mercy Clinic Cardiology - Fort Smith	Fort Smith	Arkansas
United States	Parkview Cancer Institute	Fort Wayne	Indiana
United States	Texas Heart Institute	Houston	Texas
United States	MedStar Health Research Institute	Hyattsville	Maryland
United States	St. Luke's Hospital Kansas City	Kansas City	Missouri
United States	University of Kansas Medical Center Research Institute	Kansas City	Kansas
United States	OSF HealthCare Cardiovascular Institute	Peoria	Illinois
United States	Robert Wood Johnson Medical School Dept. of Medicine	Piscataway	New Jersey
United States	Mercy Health Research	Washington	Missouri
United States	Central Dupage Hospital	Winfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Week 12
Secondary	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.	Baseline, Week 12
Secondary	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.	Baseline, Week 12
Secondary	Change From Baseline in KCCQ Clinical Summary Score at 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.	Baseline, Week 12
Secondary	Change From Baseline in KCCQ Overall Summary Score at 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.	Baseline, Week 12