Effect of Henagliflozin on Cardiac Function in Type 2 Diabetes Patients With Chronic Heart Failure (HERO-HF)
NCT ID: NCT05742230
Last Updated: 2023-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1932 participants
INTERVENTIONAL
2023-04-15
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Henagliflozin 10 mg
Single 10 mg tablet, administered orally once daily for 12 weeks
Henagliflozin 10 mg
Participants will receive 10 mg single oral tablets orally once daily.
blank control
standard treatment
blank control
standard treatment
Interventions
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Henagliflozin 10 mg
Participants will receive 10 mg single oral tablets orally once daily.
blank control
standard treatment
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Jian'an Wang, MD
Role: PRINCIPAL_INVESTIGATOR
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Locations
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2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-1049
Identifier Type: -
Identifier Source: org_study_id
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