Status:
UNKNOWN
Henagliflozin in Patients With Atrial Fibrillation
Lead Sponsor:
Beijing Anzhen Hospital
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 lea...
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 red...
Eligibility Criteria
Inclusion
- ≥18 and ≤80 years old
- Persistent AF: ECG or Holter diagnosed AF for more than 1 month
- LA enlargement (LAAPD ≥40mm and \<60mm)
- 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
- Intention of catheter ablation of AF in the next 6 months
- Cardiovascular events (myocardial infarction, etc.) or cardiac surgery in the past 3 months
- 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%
- 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)
- Type 2 diabetic patients with CKD (eGFR30-60mL/min ·1.73m2)
- Diabetic patients who are using SGLT2i to control blood glucose
- Type 1 diabetes
- Severe renal insufficiency (eGFR \< 30mL/ min ·1.73m2), end-stage renal disease or dialysis patients
- Previous diabetic ketoacidosis
- Previous allergic reactions to SGLT2i
- Severe hypoglycemia attacks in the past 12 months
- Pregnant
- Life expectancy less than 1 year
- Subjects currently participating in other interventional clinical trials
- Cardiac MRI contraindications (previous implantation of a metal device in the body) or refusal to undergo cardiac MRI
- 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
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05252624
Start Date
September 1 2022
End Date
September 30 2023
Last Update
May 23 2022
Active Locations (1)
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1
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100029