Henagliflozin in Patients With Atrial Fibrillation

Beijing Anzhen Hospital100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

100

Conditions

Atrial Fibrillation

Interventions

placeboDRUG

Placebo tablet manufactured to mimic henagliflozin 5 mg tablet

Henagliflozin 5Mg TabDRUG

Single oral tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Change in left atrial minimal volume index

Changes from baseline in left atrial minimal volume index in patients with AF treated with henagliflozin versus placebo using cardiac MRI.

Time frame: 6 months

Secondary Outcomes

Atrial fibrillation quality of life

Changes from baseline in quality of life measured by the Atrial Fibrillation Effect on QualiTy of Life (AFEQT) survey. The AFEQT questionnaire has 20 items from 4 individual domains, including symptoms, daily activities, treatment concern, and treatment satisfaction. Each item is presented with a 7-point Likert response. Raw scores within each domain are transformed to a 0 to 100 scale, where a score of 0 indicates the most severe symptoms or disability and a score of 100 indicates no limitation or disability.

Time frame: 6 months

Change in left ventricular mass

Changes from baseline in LV mass as measured by cardiac MR in patients with AF treated with henagliflozin versus placebo.

Time frame: 6 months

Change in left ventricular end-diastolic volume index

Changes from baseline in LV end-diastolic volume index as measured by cardiac MR in patients with AF treated with henagliflozin versus placebo.

Time frame: 6 months

Change in left ventricular end-systolic volume index

Changes from baseline in LV end-systolic volume index as measured by cardiac MR in patients with AF treated with henagliflozin versus placebo.

Time frame: 6 months

Change in left ventricular global longitudinal strain

Changes from baseline in LV global longitudinal strain as measured by cardiac MR in patients with AF treated with henagliflozin versus placebo.

Central Contacts

Chao Jiang, Dr

CONTACT

13811168422 superj@zju.edu.cn

Data from ClinicalTrials.gov

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