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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04252287|
Recruitment Status : Active, not recruiting
First Posted : February 5, 2020
Last Update Posted : September 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Drug: Canagliflozin 100 mg Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||476 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 :||October 8, 2021|
|Estimated Study Completion Date :||November 7, 2021|
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.
Placebo Comparator: Placebo
Participants will be administered matching placebo capsules orally once daily for 12 weeks.
Participants will receive matching placebo capsules orally once daily.
- 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.
- 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.
- 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.
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
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|