Heart FailureHERO-HFNCT05742230
Effect of Henagliflozin on Cardiac Function in Type 2 Diabetes Patients With Chronic Heart Failure (HERO-HF)
A study testing Henagliflozin 10 mg in people with Heart Failure, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Henagliflozin 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,932 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with T2DM aged ≥18 years
- 6.5%≤HbA1c≤11%
- Clinically stable symptomatic heart failure
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
Jun Jiang, MD, 13588706891, drjayj@hotmail.com
About this study
Official title: Effect of Henagliflozin on Cardiac Function in Type 2 Diabetes Patients With Chronic Heart Failure: a Multicenter, Prospective, Pragmatic Randomized Controlled Trial
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).
- Conditions
- Heart Failure
- Being tested
- Henagliflozin 10 mg, blank control
- Keywords
- Heart Failure, Henagliflozin
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Henagliflozin 10 mgDrug
Participants will receive 10 mg single oral tablets orally once daily.
blank controlDrug
standard treatment
| Study group | Role | What they receive |
|---|---|---|
| Henagliflozin 10 mg | Experimental | Single 10 mg tablet, administered orally once daily for 12 weeks Receives: Drug: Henagliflozin 10 mg |
| blank control | Other | standard treatment Receives: Drug: blank control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (13)
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.
Measured: 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.
Measured: 4 weeks, 12 weeks
Change From Baseline in NT-proBNP or BNP at Week 4, 12
Measured: 4 weeks, 12 weeks
Change From Baseline in LV ejection fraction at Week 4, 12
Measured: 4 weeks, 12 weeks
Change From Baseline in E/e' at Week 4, 12
Measured: 4 weeks, 12 weeks
Change From Baseline in UACR at Week 4, 12
Measured: 4 weeks, 12 weeks
Change From Baseline in eGFR at Week 4, 12
Measured: 4 weeks, 12 weeks
Change From Baseline in HbA1c at Week 12
Measured: 12 weeks
Change From Baseline in body weight at Week 4, 12
Measured: 4 weeks, 12 weeks
Change From Baseline in BMI at Week 4, 12
Measured: 4 weeks, 12 weeks
Change From Baseline in waist circumference at Week 4, 12
Measured: 4 weeks, 12 weeks
Change From Baseline in lipids at Week 4, 12
Measured: 4 weeks, 12 weeks
Change From Baseline in blood pressure at Week 4, 12
Measured: 4 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start15 Apr 2023 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,932 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian'an Wang, MD, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742230
- Sponsor's protocol ID
- 2022-1049
- Acronym
- HERO-HF
- Status last verified
- Feb 2023
- First submitted
- 15 Feb 2023
- Last updated
- 23 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Henagliflozin on Cardiac Function in Type 2 Diabetes Patients With Chronic Heart Failure: a Multicenter, Prospective, Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05742230
- Acronym / sponsor ID
- HERO-HF / 2022-1049
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Henagliflozin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,932 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 15 Apr 2023 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Henagliflozin 10 mg | Experimental | Drug: Henagliflozin 10 mgSingle 10 mg tablet, administered orally once daily for 12 weeks |
| blank control | Other | Drug: blank controlstandard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with T2DM aged ≥18 years
- 6.5%≤HbA1c≤11%
- Clinically stable symptomatic heart failure
- Symptoms of heart failure at visit 1 (NYHA II-IV)
- KCCQ-OSS score < 80 at screening visit
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Henagliflozin 10 mgParticipants will receive 10 mg single oral tablets orally once daily. | Drug | Henagliflozin 10 mg |
| blank controlstandard treatment | Drug | blank control |
Primary outcome
Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) at Week 12
Time frame: 12 weeks
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.
13 secondary outcomes
Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) at Week 4
Time frame: 4 weeks
Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 4, 12
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian'an Wang, MD principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Henagliflozin 10 mg in people with Heart Failure, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Jiang, MD (13588706891, drjayj@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) at Week 12 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.