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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

476

participants targeted

Target at P50-P75 for phase_3 heart-failure

Timeline

Completed

Started Mar 2020

Shorter than P25 for phase_3 heart-failure

Geographic Reach

1 country

18 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.7 years study duration

First Submitted

Initial submission to the registry

January 31, 2020

Completed

5 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed

1 month until next milestone

Study Start

First participant enrolled

March 10, 2020

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2021

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

January 12, 2023

Completed

Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

1.7 years

First QC Date

January 31, 2020

Results QC Date

November 7, 2022

Last Update Submit

March 28, 2025

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

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 Outcomes (4)

Change From Baseline in Total Daily Step Count at Week 12
Baseline, Week 12
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 Clinical Summary Score at Week 12
Baseline, Week 12
Change From Baseline in KCCQ Overall Summary Score at Week 12
Baseline, Week 12

Study Arms (2)

Canagliflozin 100 mg

EXPERIMENTAL

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

Drug: Canagliflozin 100 mg

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Canagliflozin 100 mgDRUG

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

Also known as: JNJ-28431754, INVOKANA

Canagliflozin 100 mg

PlaceboDRUG

Participants will receive matching placebo capsules orally once daily.

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

\- 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Janssen Research & Development, LLClead

Study Sites (18)

Mercy Clinic Cardiology - Fort Smith

Fort Smith, Arkansas, 72903, United States

Location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Clearwater Cardiovascular Consultants

Clearwater, Florida, 33756, United States

Location

Emory University

Atlanta, Georgia, 30022, United States

Location

St Lukes Regional Medical

Boise, Idaho, 83712, United States

Location

OSF HealthCare Cardiovascular Institute

Peoria, Illinois, 61614, United States

Location

Central Dupage Hospital

Winfield, Illinois, 60190, United States

Location

Parkview Cancer Institute

Fort Wayne, Indiana, 46845, United States

Location

University of Kansas Medical Center Research Institute

Kansas City, Kansas, 66160, United States

Location

MedStar Health Research Institute

Hyattsville, Maryland, 20782, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

St. Luke's Hospital Kansas City

Kansas City, Missouri, 64111, United States

Location

Mercy Health Research

Washington, Missouri, 63090, United States

Location

Robert Wood Johnson Medical School Dept. of Medicine

Piscataway, New Jersey, 08854, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Thomas Spann Clinic

Corpus Christi, Texas, 78412, United States

Location

Texas Heart Institute

Houston, Texas, 77030, United States

Location

Related Publications (5)

Mohebi R, Jones PG, Spertus JA, Lingvay I, Lanfear DE, Gosch KL, Birmingham M, Kosiborod MN, Butler J, Januzzi JL Jr. Early Longitudinal Change in Heart Failure Health Status Following Initiation of Canagliflozin. JACC Heart Fail. 2024 Apr;12(4):711-718. doi: 10.1016/j.jchf.2024.01.005. Epub 2024 Feb 21.
PMID: 38385941DERIVED
Golbus JR, Gosch K, Birmingham MC, Butler J, Lingvay I, Lanfear DE, Abbate A, Kosiborod ML, Damaraju CV, Januzzi JL Jr, Spertus J, Nallamothu BK. Association Between Wearable Device Measured Activity and Patient-Reported Outcomes for Heart Failure. JACC Heart Fail. 2023 Nov;11(11):1521-1530. doi: 10.1016/j.jchf.2023.05.033. Epub 2023 Jul 26.
PMID: 37498273DERIVED
Nassif M, Birmingham MC, Lanfear DE, Golbus JR, Gupta B, Fawcett C, Harrison MC, Spertus JA. 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. J Card Fail. 2023 Jun;29(6):863-869. doi: 10.1016/j.cardfail.2023.04.001. Epub 2023 Apr 10.
PMID: 37040839DERIVED
Spertus JA, Birmingham MC, Nassif M, Damaraju CV, Abbate A, Butler J, Lanfear DE, Lingvay I, Kosiborod MN, Januzzi JL. The SGLT2 inhibitor canagliflozin in heart failure: the CHIEF-HF remote, patient-centered randomized trial. Nat Med. 2022 Apr;28(4):809-813. doi: 10.1038/s41591-022-01703-8. Epub 2022 Feb 28.
PMID: 35228753DERIVED
Spertus JA, Birmingham MC, Butler J, Lingvay I, Lanfear DE, Abbate A, Kosiborod ML, Fawcett C, Burton P, Damaraju CV, Januzzi JL, Whang J. Novel Trial Design: CHIEF-HF. Circ Heart Fail. 2021 Mar;14(3):e007767. doi: 10.1161/CIRCHEARTFAILURE.120.007767. Epub 2021 Mar 16.
PMID: 33724883DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Canagliflozin

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlucosidesGlycosidesCarbohydrates

Results Point of Contact

Title: Director CVM Health Equity
Organization: Janssen Scientific Affairs, LLC

Study Officials

Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 31, 2020

First Posted

February 5, 2020

Study Start

March 10, 2020

Primary Completion

November 9, 2021

Study Completion

November 9, 2021

Last Updated

March 30, 2025

Results First Posted

January 12, 2023

Record last verified: 2025-03

Data Sharing

IPD Sharing: Will share

Locations

US(18)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Canagliflozin 100 mg

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (18)

Related Publications (5)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations