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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Henagliflozin 10 mg | Experimental | Single 10 mg tablet, administered orally once daily for 12 weeks |
|
| blank control | Other | standard treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Henagliflozin 10 mg | Drug | Participants will receive 10 mg single oral tablets orally once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of aggravated heart failure event | up to 12 weeks | |
| Occurrence of cardiovascular (CV) death | up to 12 weeks | |
| Occurrence of major renal events |
Inclusion Criteria:
Patients with T2DM aged ≥18 years
6.5%≤HbA1c≤11%
Clinically stable symptomatic heart failure
(a) For HFrEF: (a) Ejection fraction (EF) less than or equal to (<=) 40% and (b) diagnosis of chronic heart failure within the past 18 months (B) For HFpEF: (a) EF greater than (>) 40%; (b) Diagnosis of chronic heart failure within the past 18 months
Symptoms of heart failure at visit 1 (NYHA II-IV)
KCCQ-OSS score < 80 at screening visit
NT-proBNP > 125 pg/mL, or NT proBNP > 365 pg/mL in atrial fibrillation patients; Or BNP > 35 pg/mL, or BNP > 105 pg/mL in atrial fibrillation patients at screening visit
Subject must have received (and be receiving) at least one stable optimal dose of guidelines recommended HF drugs (e.g., ACEi, ARB, ARNI, beta blockers, oral diuretics, MRA) prior to visit 1
eGFR≥30 ml/min/1.73m2 at screening visit (CKD-EPI formula)
Signed and dated written ICF
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Jiang, MD | Contact | 13588706891 | drjayj@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jian'an Wang, MD | 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2nd Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000611095 | henagliflozin |
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| blank control | Drug | standard treatment |
|
| 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 |
| up to 12 weeks |