Heart Failure Clinical Trial

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

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).

View Eligibility Criteria

Eligibility 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

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

476

Study ID:

NCT04252287

Recruitment Status:

Completed

Sponsor:

Janssen Research & Development, LLC

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 18 Locations for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

476

Study ID:

NCT04252287

Recruitment Status:

Completed

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider