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

  • STATUS
    Recruiting
  • End date
    Oct 8, 2021
  • participants needed
    1900
  • sponsor
    Janssen Research & Development, LLC
Updated on 23 November 2020
Investigator
The Medical Research Network, LLC
Primary Contact
MedStar Health Research Institute (1.7 mi away) Contact
+20 other location
ejection fraction
heart failure
diuretics
loop diuretic
spironolactone
cardiomyopathy
heart failure with preserved ejection fraction

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).

Details
Treatment Placebo, Canagliflozin 100 mg
Clinical Study IdentifierNCT04252287
SponsorJanssen Research & Development, LLC
Last Modified on23 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Heart disease or Cardiac Disease or Congestive Heart Failure or Heart failure?
Do you have any of these conditions: Congestive Heart Failure or congestive heart disease or Cardiac Disease or Heart failure or Heart disease or cardiac failure?
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
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