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History of Changes for Study: NCT04252287
A Study on Impact of Canagliflozin on Health Status, Quality of Life, and Functional Status in Heart Failure (CHIEF-HF)
Latest version (submitted December 20, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 31, 2020 None (earliest Version on record)
2 February 12, 2020 Study Status and Oversight
3 March 6, 2020 Study Status and Oversight
4 March 17, 2020 Recruitment Status, Contacts/Locations, Study Status and Eligibility
5 April 20, 2020 Study Status and Contacts/Locations
6 June 22, 2020 Contacts/Locations, Study Status and Eligibility
7 July 22, 2020 Contacts/Locations and Study Status
8 July 23, 2020 Study Status
9 August 21, 2020 Contacts/Locations and Study Status
10 September 18, 2020 Contacts/Locations and Study Status
11 October 16, 2020 Study Status and Contacts/Locations
12 November 13, 2020 Study Status and Contacts/Locations
13 December 11, 2020 Study Status and Contacts/Locations
14 February 4, 2021 Study Status
15 March 11, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
16 April 2, 2021 Study Status and Study Design
17 April 30, 2021 Study Status
18 June 24, 2021 Study Status
19 September 16, 2021 Study Status
20 October 15, 2021 Study Status
21 November 12, 2021 Study Status
22 December 7, 2021 Recruitment Status and Study Status
23 November 7, 2022
Quality Control Review has not concluded Returned: November 30, 2022
Outcome Measures, Study Status, Document Section
24 December 20, 2022 Study Status, Document Section, Outcome Measures
Comparison Format:
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Study NCT04252287
Submitted Date:  January 31, 2020 (v1)
Open or close this module Study Identification
Unique Protocol ID: CR108750
Brief Title: A Study on Impact of Canagliflozin on Health Status, Quality of Life, and Functional Status in Heart Failure (CHIEF-HF)
Official Title: Canagliflozin: Impact on Health Status, Quality of Life, and Functional Status in Heart Failure
Secondary IDs: 28431754HFA3002 [Janssen Research & Development, LLC]
Open or close this module Study Status
Record Verification: January 2020
Overall Status: Not yet recruiting
Study Start: February 21, 2020
Primary Completion: February 22, 2021 [Anticipated]
Study Completion: February 22, 2021 [Anticipated]
First Submitted: January 31, 2020
First Submitted that
Met QC Criteria:		 January 31, 2020
First Posted: February 5, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:		 January 31, 2020
Last Update Posted: February 5, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Janssen Research & Development, LLC
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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).
Detailed Description:
Open or close this module Conditions
Conditions: Heart Failure
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 1900 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Change from Baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) to Week 12
[ Time Frame: 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
[ Time Frame: 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
[ Time Frame: 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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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) HFrEF: (a) ejection fraction (EF) less than (<) 40 percent (%); (b) a primary diagnosis of HF or 2 outpatient visits for HF in the past 1 year (B) HFpEF: (a) EF greater than (>) 40%; (b) a primary diagnosis of HF or 2 outpatient visits for HF; (c) on a loop diuretic in the past 1 year

  • Have a baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) score of >40 and <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 3 months prior to enrollment
  • 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 4 weeks prior to enrollment
  • Have stage 4 or 5 Chronic Kidney Disease (that is, estimated glomerular filtration rate [eGFR] <30 milliliter per minute [ml/min] on dialysis)
  • Have a diagnosis of hypotension within 30 days of the screening visit
Open or close this module Contacts/Locations
Central Contact Person: Study Contact
Telephone: 844-434-4210
Email: JNJ.CT@sylogent.com
Study Officials: Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
Locations: United States, Kansas
University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States, 66160
United States, Maryland
MedStar Health Research Institute
Hyattsville, Maryland, United States, 20782
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
United States, Missouri
Mercy Health Research
Washington, Missouri, United States, 63090
Open or close this module IPDSharing
Plan to Share IPD: Yes

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Supporting Information:
Time Frame:
Access Criteria:
URL: https://www.janssen.com/clinical-trials/transparency
Open or close this module References
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services