Henagliflozin in Patients With Atrial Fibrillation

NCT ID: NCT05252624

Last Updated: 2022-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-09-30

Brief Summary

The HENA-AF trial will evaluate the effects of henagliflozin on cardiac structure, function, and biomarkers of HF in patients with AF. Participants with persistent AF, enlarged left atrium, and at least another cardiovascular risk factor will be randomized to henagliflozin or placebo. Cardiac MRI will be performed at baseline and at 6 months to measure the changes in cardiac structure and function. The primary hypothesis is that henagliflozin will reduce the left atrial volume index at 6 months in patients with AF.

Detailed Description

Atrial fibrillation (AF) is a major public health burden worldwide. Heart failure (HF) is one of the most common causes of death in patients with AF. Clinical trials have indicated that SGLT2i can reduce the risk of AF and HF in patients with diabetes, and improve the prognosis in patients with HF. However, whether SGLT2i can improve cardiac function and reduce the risk of HF in patients with AF remains unclear. The purpose of the HENA-AF trial is to evaluate the effects of henagliflozin on cardiac structure, function, and biomarkers of HF in patients with AF.

The HENA-AF trial will include approximately 100 persistent AF patients with enlarged left atrium and at least another cardiovascular risk factor. Participants will be randomized to henagliflozin or placebo. Cardiac MRI will be performed at baseline and at 6 months to measure the changes in cardiac structure and function. The primary hypothesis is that henagliflozin will reduce the left atrial volume index at 6 months in patients with AF.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Active Comparator: Henagliflozin

Single 5 mg tablet, administered orally once daily for 6 months

Group Type: ACTIVE_COMPARATOR

Henagliflozin 5Mg Tab

Intervention Type: DRUG

Single oral tablet

Placebo Comparator: Placebo

Single 5 mg tablet, administered orally once daily for 6 months

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Placebo tablet manufactured to mimic henagliflozin 5 mg tablet

Interventions

placebo

Placebo tablet manufactured to mimic henagliflozin 5 mg tablet

Intervention Type: DRUG

Henagliflozin 5Mg Tab

Single oral tablet

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. ≥18 and ≤80 years old

2. Persistent AF: ECG or Holter diagnosed AF for more than 1 month

3. LA enlargement (LAAPD ≥40mm and <60mm)

4. One or more risk factors as follows: (1) ≥65 years old; (2) LVH: echocardiographic calculation of left ventricular mass index (LVMI) male ≥115g/m2; female ≥95g/m2 (LVMI=LVM/BSA,LVM=1.04 × [(LVID+IVST+LVPWT) 3-LVID3] * 0.8 * 0.6) BSA (m2) =0.0061 * height (cm) + 0.0128 * weight (kg)-0.1529; (3) Coronary heart disease (CHD): CHD diagnosed by coronary angiography or CTA, or previous history of myocardial infarction, or revascularization (PCI, CABG); (4) Peripheral artery disease (PAD): imaging examination (ultrasound, CTA, MRA or angiography) indicates carotid or lower extremity artery stenosis >50%. Or peripheral vascular revascularization (stent or endarterectomy); (5) Obesity: BMI ≥28

Exclusion Criteria

1. Intention of catheter ablation of AF in the next 6 months

2. Cardiovascular events (myocardial infarction, etc.) or cardiac surgery in the past 3 months

3. Clinically diagnosed heart failure (objective evidence of elevated natriuretic peptide levels and/or cardiogenic pulmonary/systemic congestion on the basis of structural and/or functional abnormalities) or left ventricular ejection fraction (LVEF) <40%

4. Type 2 diabetic patients with ASCVD or high-risk cardiovascular risk factors (ASCVD includes acute coronary syndrome, stable coronary heart disease, revascularization, ischemic cardiomyopathy, ischemic stroke, transient ischemic attack, peripheral atherosclerotic disease. High-risk cardiovascular risk factors include age ≥55 years old, coronary artery/carotid artery/lower extremity artery stenosis >50%, or left ventricular hypertrophy)

5. Type 2 diabetic patients with CKD (eGFR30-60mL/min ·1.73m2)

6. Diabetic patients who are using SGLT2i to control blood glucose

7. Type 1 diabetes

8. Severe renal insufficiency (eGFR < 30mL/ min ·1.73m2), end-stage renal disease or dialysis patients

9. Previous diabetic ketoacidosis

10. Previous allergic reactions to SGLT2i

11. Severe hypoglycemia attacks in the past 12 months

12. Pregnant

13. Life expectancy less than 1 year

14. Subjects currently participating in other interventional clinical trials

15. Cardiac MRI contraindications (previous implantation of a metal device in the body) or refusal to undergo cardiac MRI

16. The researchers determine that there are factors that will affect the subjects' compliance with the intervention. Such as alcohol abuse, drug abuse, or behavioral disorders

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Anzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chang sheng Ma

Director of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deyong Long

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital

Changsheng Ma

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital

Jianzeng Dong

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital

Locations

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Chao Jiang, Dr

Role: CONTACT

superj@zju.edu.cn

13811168422

Facility Contacts

Chao Jiang, MD

Role: primary

superj@zju.edu.cn

13811168422

Other Identifiers

2022-HENA

Identifier Type: -

Identifier Source: org_study_id