The purpose of this study is to determine the superiority of the effectiveness of Henagliflozin 10 milligram (mg) daily versus blank control in participants with type II diabetes (T2DM) and symptomatic heart failure (HF) in improving the overall Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,932
Participants will receive 10 mg single oral tablets orally once daily.
standard treatment
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGChange From Baseline in Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) at 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-CSS is defined as the mean of the following available summary scores: Physical Limitation Score and Total Symptom Score.
Time frame: 12 weeks
Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) at Week 4
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-CSS is defined as the mean of the following available summary scores: Physical Limitation Score and Total Symptom Score.
Time frame: 4 weeks
Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 4, 12
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.
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Time frame: 4 weeks, 12 weeks
Change From Baseline in NT-proBNP or BNP at Week 4, 12
Time frame: 4 weeks, 12 weeks
Change From Baseline in LV ejection fraction at Week 4, 12
Time frame: 4 weeks, 12 weeks
Change From Baseline in E/e' at Week 4, 12
Time frame: 4 weeks, 12 weeks
Change From Baseline in UACR at Week 4, 12
Time frame: 4 weeks, 12 weeks
Change From Baseline in eGFR at Week 4, 12
Time frame: 4 weeks, 12 weeks
Change From Baseline in HbA1c at Week 12
Time frame: 12 weeks
Change From Baseline in body weight at Week 4, 12
Time frame: 4 weeks, 12 weeks
Change From Baseline in BMI at Week 4, 12
Time frame: 4 weeks, 12 weeks
Change From Baseline in waist circumference at Week 4, 12
Time frame: 4 weeks, 12 weeks
Change From Baseline in lipids at Week 4, 12
Time frame: 4 weeks, 12 weeks
Change From Baseline in blood pressure at Week 4, 12
Time frame: 4 weeks, 12 weeks