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Clinical Trial Details

Trial ID: L2361
Source ID: NCT05742230
Associated Drug: Henagliflozin 10 Mg
Title: Effect of Henagliflozin on Cardiac Function in Type 2 Diabetes Patients With Chronic Heart Failure (HERO-HF)
Acronym: HERO-HF
Status: RECRUITING
Study Results: NO
Results:
Conditions: Heart Failure
Interventions: DRUG: Henagliflozin 10 mg|DRUG: blank control
Outcome Measures: Primary: Change 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., 12 weeks | Secondary: 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., 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., 4 weeks, 12 weeks|Change From Baseline in NT-proBNP or BNP at Week 4, 12, 4 weeks, 12 weeks|Change From Baseline in LV ejection fraction at Week 4, 12, 4 weeks, 12 weeks|Change From Baseline in E/e' at Week 4, 12, 4 weeks, 12 weeks|Change From Baseline in UACR at Week 4, 12, 4 weeks, 12 weeks|Change From Baseline in eGFR at Week 4, 12, 4 weeks, 12 weeks|Change From Baseline in HbA1c at Week 12, 12 weeks|Change From Baseline in body weight at Week 4, 12, 4 weeks, 12 weeks|Change From Baseline in BMI at Week 4, 12, 4 weeks, 12 weeks|Change From Baseline in waist circumference at Week 4, 12, 4 weeks, 12 weeks|Change From Baseline in lipids at Week 4, 12, 4 weeks, 12 weeks|Change From Baseline in blood pressure at Week 4, 12, 4 weeks, 12 weeks | Other: Occurrence of aggravated heart failure event, up to 12 weeks|Occurrence of cardiovascular (CV) death, up to 12 weeks|Occurrence of major renal events, up to 12 weeks
Sponsor/Collaborators: Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 1932
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-04-15
Completion Date: 2025-12-31
Results First Posted:
Last Update Posted: 2023-02-23
Locations: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China
URL: https://clinicaltrials.gov/show/NCT05742230