Canagliflozin: Impact on Health Status, Quality of Life, and Functional Status in Heart Failure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 476
- 试验地点
- 18
- 主要终点
- Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 12
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Canagliflozin 100 mg
Participants will be administered 100 milligram (mg) immediate-release, over-encapsulated tablets (as a capsule) orally once daily for 12 weeks.
干预措施: Canagliflozin 100 mg (Drug)
Placebo
Participants will be administered matching placebo capsules orally once daily for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 12
时间窗: Baseline, Week 12
Change from baseline in KCCQ-TSS was reported. KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ-TSS was average of domains- symptom frequency and symptom burden, and transformed to a single score which ranged from 0 (worst) to 100 (the best possible status), where the higher score reflected better health status.
次要结局
- Change From Baseline in Total Daily Step Count at Week 12(Baseline, Week 12)
- Change From Baseline in KCCQ Individual Domain Scores (Physical Limitation and Quality of Life) at Week 12(Baseline, Week 12)
- Change From Baseline in KCCQ Overall Summary Score at Week 12(Baseline, Week 12)
- Change From Baseline in KCCQ Clinical Summary Score at Week 12(Baseline, Week 12)