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

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT04252287
Collaborator
(none)
476
Enrollment
18
Locations
2
Arms
20
Actual Duration (Months)
26.4
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Canagliflozin 100 mg
  • Drug: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
476 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Canagliflozin: Impact on Health Status, Quality of Life, and Functional Status in Heart Failure
Actual Study Start Date :
Mar 10, 2020
Actual Primary Completion Date :
Nov 9, 2021
Actual Study Completion Date :
Nov 9, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Canagliflozin 100 mg

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
Participants will receive 100 mg immediate-release, over-encapsulated tablets (as a capsule) orally once daily.
Other Names:
  • JNJ-28431754
  • INVOKANA

    		•
    Placebo Comparator: Placebo

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

    Drug: Placebo
    Participants will receive matching placebo capsules orally once daily.

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) to Week 12 [Baseline to Week 12]

      Change from baseline in KCCQ-TSS will be reported. The KCCQ is a 23-item, self-administered questionnaire with score range of 0 to 100, and higher scores indicating better health.

    Secondary Outcome Measures

    1. Change in Total Daily Step Count from Baseline to Week 12 [Baseline to Week 12]

      Change from baseline in total daily step count will be reported. Step count will be measured from the Fitbit device data. The Fitbit app on the participant's phone will collect all data from the Fitbit device.

    2. Change from Baseline in KCCQ Individual Domain Scores to Week 12 [Baseline to Week 12]

      The KCCQ is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status over eight domains: physical limitation; symptom stability; symptom frequency; symptom burden; total symptom; social limitation; self-efficacy; and quality of life. Summary scores will be computed: the "Clinical Summary Score" including total symptom and physical limitation scores; and the "Overall Summary Score" including the total symptom, physical limitation, social limitations and quality of life scores. Scores are transformed into values ranging from 0 to 100, with higher scores indicating more favorable health status. Improvement in physical limitation, quality of life, clinical summary, and overall summary will be assessed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mercy Clinic Cardiology - Fort Smith Fort Smith Arkansas United States 72903
    2 University of Colorado - Anschutz Medical Campus Aurora Colorado United States 80045
    3 Clearwater Cardiovascular Consultants Clearwater Florida United States 33756
    4 Emory University Atlanta Georgia United States 30022
    5 St Lukes Regional Medical Boise Idaho United States 83712
    6 OSF HealthCare Cardiovascular Institute Peoria Illinois United States 61614
    7 Central Dupage Hospital Winfield Illinois United States 60190
    8 Parkview Cancer Institute Fort Wayne Indiana United States 46845
    9 University of Kansas Medical Center Research Institute Kansas City Kansas United States 66160
    10 MedStar Health Research Institute Hyattsville Maryland United States 20782
    11 University of Michigan Ann Arbor Michigan United States 48109
    12 Henry Ford Hospital Detroit Michigan United States 48202
    13 St. Luke's Hospital Kansas City Kansas City Missouri United States 64111
    14 Mercy Health Research Washington Missouri United States 63090
    15 Robert Wood Johnson Medical School Dept. of Medicine Piscataway New Jersey United States 08854
    16 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106
    17 Thomas Spann Clinic Corpus Christi Texas United States 78412
    18 Texas Heart Institute Houston Texas United States 30322

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

    • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT04252287
    Other Study ID Numbers:
    • CR108750
    • 28431754HFA3002
    First Posted:
    Feb 5, 2020
    Last Update Posted:
    Dec 8, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Heart Failure
    Canagliflozin

    Study Results

    No Results Posted as of Dec 8, 2021