Back to resultsEffect of Henagliflozin on Cardiac Function in Type 2 Diabetes Patients With Chronic Heart Failure (HERO-HF) (HERO-HF)
Primary Purpose
Heart Failure
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Henagliflozin 10 mg
blank control
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Henagliflozin
Eligibility Criteria
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: Pregnant and lactating women and women of childbearing age who do not want to use reliable contraception Known allergy to Henagliflozin Hospitalization for acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery within 4 weeks before the screening visit Acute decompensated heart failure or hospitalization for decompensated heart failure within 4 weeks History of heart transplantation or ventricular assist device (VAD), or intention to heart transplantation or VAD Perinatal or chemotherapy-induced cardiomyopathy within 12 months Documented untreated ventricular arrhythmias with syncope within 3 months Diagnosed respiratory diseases Type I diabetes T2DM with history of ketoacidosis (DKA) Uncontrolled hypertension, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg at screening visit Symptomatic hypotension and/or systolic blood pressure <90 mmHg at visit 0 or visit 1, or hypovolemia History of recurrent urinary and reproductive tract infections Current use or prior use of a SGLT-2i or GLP-1RA within 3 months Diagnosed malignant tumors Further exclusion criteria apply
Sites / Locations
- 2nd Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Henagliflozin 10 mg
blank control
Arm Description
Single 10 mg tablet, administered orally once daily for 12 weeks
standard treatment
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Change From Baseline in NT-proBNP or BNP at Week 4, 12
Change From Baseline in LV ejection fraction at Week 4, 12
Change From Baseline in E/e' at Week 4, 12
Change From Baseline in UACR at Week 4, 12
Change From Baseline in eGFR at Week 4, 12
Change From Baseline in HbA1c at Week 12
Change From Baseline in body weight at Week 4, 12
Change From Baseline in BMI at Week 4, 12
Change From Baseline in waist circumference at Week 4, 12
Change From Baseline in lipids at Week 4, 12
Change From Baseline in blood pressure at Week 4, 12
Full Information
NCT ID
NCT05742230
First Posted
February 15, 2023
Last Updated
February 15, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05742230
Brief Title
Effect of Henagliflozin on Cardiac Function in Type 2 Diabetes Patients With Chronic Heart Failure (HERO-HF)
Acronym
HERO-HF
Official Title
Effect of Henagliflozin on Cardiac Function in Type 2 Diabetes Patients With Chronic Heart Failure: a Multicenter, Prospective, Pragmatic Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2023 (Anticipated)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Henagliflozin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1932 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Henagliflozin 10 mg
Arm Type
Experimental
Arm Description
Single 10 mg tablet, administered orally once daily for 12 weeks
Arm Title
blank control
Arm Type
Other
Arm Description
standard treatment
Intervention Type
Drug
Intervention Name(s)
Henagliflozin 10 mg
Intervention Description
Participants will receive 10 mg single oral tablets orally once daily.
Intervention Type
Drug
Intervention Name(s)
blank control
Intervention Description
standard treatment
Primary Outcome Measure Information:
Title
Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) at Week 12
Description
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
Secondary Outcome Measure Information:
Title
Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) at Week 4
Description
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
Title
Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 4, 12
Description
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.
Time Frame
4 weeks, 12 weeks
Title
Change From Baseline in NT-proBNP or BNP at Week 4, 12
Time Frame
4 weeks, 12 weeks
Title
Change From Baseline in LV ejection fraction at Week 4, 12
Time Frame
4 weeks, 12 weeks
Title
Change From Baseline in E/e' at Week 4, 12
Time Frame
4 weeks, 12 weeks
Title
Change From Baseline in UACR at Week 4, 12
Time Frame
4 weeks, 12 weeks
Title
Change From Baseline in eGFR at Week 4, 12
Time Frame
4 weeks, 12 weeks
Title
Change From Baseline in HbA1c at Week 12
Time Frame
12 weeks
Title
Change From Baseline in body weight at Week 4, 12
Time Frame
4 weeks, 12 weeks
Title
Change From Baseline in BMI at Week 4, 12
Time Frame
4 weeks, 12 weeks
Title
Change From Baseline in waist circumference at Week 4, 12
Time Frame
4 weeks, 12 weeks
Title
Change From Baseline in lipids at Week 4, 12
Time Frame
4 weeks, 12 weeks
Title
Change From Baseline in blood pressure at Week 4, 12
Time Frame
4 weeks, 12 weeks
Other Pre-specified Outcome Measures:
Title
Occurrence of aggravated heart failure event
Time Frame
up to 12 weeks
Title
Occurrence of cardiovascular (CV) death
Time Frame
up to 12 weeks
Title
Occurrence of major renal events
Time Frame
up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Pregnant and lactating women and women of childbearing age who do not want to use reliable contraception
Known allergy to Henagliflozin
Hospitalization for acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery within 4 weeks before the screening visit
Acute decompensated heart failure or hospitalization for decompensated heart failure within 4 weeks
History of heart transplantation or ventricular assist device (VAD), or intention to heart transplantation or VAD
Perinatal or chemotherapy-induced cardiomyopathy within 12 months
Documented untreated ventricular arrhythmias with syncope within 3 months
Diagnosed respiratory diseases
Type I diabetes
T2DM with history of ketoacidosis (DKA)
Uncontrolled hypertension, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg at screening visit
Symptomatic hypotension and/or systolic blood pressure <90 mmHg at visit 0 or visit 1, or hypovolemia
History of recurrent urinary and reproductive tract infections
Current use or prior use of a SGLT-2i or GLP-1RA within 3 months
Diagnosed malignant tumors
Further exclusion criteria apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Jiang, MD
Phone
13588706891
Email
drjayj@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian'an Wang, MD
Organizational Affiliation
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
2nd Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Jiang, MD
Phone
13588706891
Email
drjayj@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Effect of Henagliflozin on Cardiac Function in Type 2 Diabetes Patients With Chronic Heart Failure (HERO-HF)
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