Effect of Henagliflozin on Cardiac Function in Type 2 Diabetes Patients With Chronic Heart Failure (HERO-HF)

NCT05742230 | Unknown

• 1 other identifier: 2022-1049
• Study Type: interventional
• Target: 1,932
• Locations: 1 country
• Sites: 1

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).

Conditions

Heart Failure

Keywords

Heart Failure; Henagliflozin

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (13)

• Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) at Week 4

  4 weeks

• Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 4, 12

  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

Other Outcomes (3)

• Occurrence of aggravated heart failure event

  up to 12 weeks

• Occurrence of cardiovascular (CV) death

  up to 12 weeks

• Occurrence of major renal events

  up to 12 weeks

Study Arms (2)

Henagliflozin 10 mg

EXPERIMENTAL

Single 10 mg tablet, administered orally once daily for 12 weeks

Drug: Henagliflozin 10 mg

blank control

OTHER

standard treatment

Drug: blank control

Interventions

Henagliflozin 10 mg DRUG

Participants will receive 10 mg single oral tablets orally once daily.

Henagliflozin 10 mg

blank control DRUG

standard treatment

blank control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with T2DM aged ≥18 years
• %≤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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

henagliflozin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jian'an Wang, MD

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Jiang, MD

CONTACT

13588706891; drjayj@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: February 23, 2023
• Study Start: April 15, 2023
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2025
• Last Updated: February 23, 2023

Record last verified: 2023-02

Locations

CN (1)