Henagliflozin in Patients With Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— HENA-AF  

Official title:

Impact of Henagliflozin on Cardiac Structure, Function and Biomarkers of Heart Failure in Patients With Persistent Atrial Fibrillation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05252624
• Other study ID #: 2022-HENA
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 1, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: May 2022
• Source: Beijing Anzhen Hospital
• Contact: Chao Jiang, Dr
• Phone: 13811168422
• Email: superj[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• placebo
Placebo tablet manufactured to mimic henagliflozin 5 mg tablet
• Henagliflozin 5Mg Tab
Single oral tablet

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	Change in left ventricular ejection fraction	Changes from baseline in LV ejection fraction as measured by cardiac MR in patients with AF treated with henagliflozin versus placebo.	6 months
Secondary	Change in extracellular volume	Changes from baseline in extracellular volume (ECV) assessed using cardiac MR T1 mapping in patients with AF treated with henagliflozin versus placebo.	6 months
Secondary	Change in left atrial ejection fraction	Changes from baseline in LA ejection fraction as measured by cardiac MR in patients with AF treated with henagliflozin versus placebo.	6 months
Secondary	Change in left atrial global longitudinal strain	Changes from baseline in LA global longitudinal strain as measured by cardiac MR in patients with AF treated with henagliflozin versus placebo.	6 months
Secondary	Change in right ventricular mass	Changes from baseline in RV mass as measured by cardiac MR in patients with AF treated with henagliflozin versus placebo.	6 months
Secondary	Change in right atrial volume index	Changes from baseline in RA Volume Index as measured by cardiac MR in patients with AF treated with henagliflozin versus placebo.	6 months
Secondary	Change in biomarkers of heart failure	Changes from baseline in biomarkers of heart failure (such as NT-proBNP) in patients with AF treated with henagliflozin versus placebo.	6 months
Secondary	Change in 6min walk test	Changes from baseline in 6min walk test in patients with AF treated with henagliflozin versus placebo.	6 months