Clinical trial NCT05742230: Effect of Henagliflozin on Cardiac Function in Type 2 Diabetes Patients With Chronic Heart Failure (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
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Henagliflozin
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 1932
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) at Week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) at Week 4
timeFrame: 4 weeks
measure: Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 4, 12
timeFrame: 4 weeks, 12 weeks
measure: Change From Baseline in NT-proBNP or BNP at Week 4, 12
timeFrame: 4 weeks, 12 weeks
measure: Change From Baseline in LV ejection fraction at Week 4, 12
timeFrame: 4 weeks, 12 weeks
measure: Change From Baseline in E/e' at Week 4, 12
timeFrame: 4 weeks, 12 weeks
measure: Change From Baseline in UACR at Week 4, 12
timeFrame: 4 weeks, 12 weeks
measure: Change From Baseline in eGFR at Week 4, 12
timeFrame: 4 weeks, 12 weeks
measure: Change From Baseline in HbA1c at Week 12
timeFrame: 12 weeks
measure: Change From Baseline in body weight at Week 4, 12
timeFrame: 4 weeks, 12 weeks
measure: Change From Baseline in BMI at Week 4, 12
timeFrame: 4 weeks, 12 weeks
measure: Change From Baseline in waist circumference at Week 4, 12
timeFrame: 4 weeks, 12 weeks
measure: Change From Baseline in lipids at Week 4, 12
timeFrame: 4 weeks, 12 weeks
measure: Change From Baseline in blood pressure at Week 4, 12
timeFrame: 4 weeks, 12 weeks
Other outcomes:
measure: Occurrence of aggravated heart failure event
timeFrame: up to 12 weeks
measure: Occurrence of cardiovascular (CV) death
timeFrame: up to 12 weeks
measure: Occurrence of major renal events
timeFrame: up to 12 weeks
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Jian'an Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: