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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04252287
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Canagliflozin 100 mg Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1900 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 : March 10, 2020
Estimated Primary Completion Date : February 22, 2021
Estimated Study Completion Date : February 22, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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.




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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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) 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252287


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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United States, Arkansas
Mercy Clinic Cardiology - Fort Smith Recruiting
Fort Smith, Arkansas, United States, 72903
United States, California
Scripps Clinic/Prebys Cardiovascular Institute Not yet recruiting
San Diego, California, United States, 92121
United States, Florida
Clearwater Cardiovascular Consultants Not yet recruiting
Clearwater, Florida, United States, 33756
United States, Georgia
Emory University Not yet recruiting
Atlanta, Georgia, United States, 30022
United States, Indiana
Parkview Cancer Institute Not yet recruiting
Fort Wayne, Indiana, United States, 46845
United States, Kansas
University of Kansas Medical Center Research Institute Not yet recruiting
Kansas City, Kansas, United States, 66160
United States, Maryland
MedStar Health Research Institute Recruiting
Hyattsville, Maryland, United States, 20782
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic - Rochester Withdrawn
Rochester, Minnesota, United States, 55905
United States, Missouri
St. Luke's Hospital Kansas City Recruiting
Kansas City, Missouri, United States, 64111
Mercy Health Research Recruiting
Washington, Missouri, United States, 63090
United States, New Jersey
Robert Wood Johnson Medical School Dept. of Medicine Not yet recruiting
Piscataway, New Jersey, United States, 08854
United States, Ohio
University Hospitals Cleveland Medical Center Not yet recruiting
Cleveland, Ohio, United States, 44106
United States, Texas
Texas Heart Institute Recruiting
Houston, Texas, United States, 30322
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Additional Information:
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04252287    
Other Study ID Numbers: CR108750
28431754HFA3002 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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

URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Canagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs