Henagliflozin in Patients With Atrial Fibrillation

NCT05252624 | Unknown Phase 3

• 1 other identifier: 2022-HENA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Heart Failure; SGLT2i; Cardiac structure; Cardiac function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Atrial fibrillation quality of life

  6 months

• Change in left ventricular mass

  6 months

• Change in left ventricular end-diastolic volume index

  6 months

• Change in left ventricular end-systolic volume index

  6 months

• Change in left ventricular global longitudinal strain

  6 months

Study Arms (2)

Active Comparator: Henagliflozin

ACTIVE COMPARATOR

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

Drug: Henagliflozin 5Mg Tab

Placebo Comparator: Placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

placebo DRUG

Placebo tablet manufactured to mimic henagliflozin 5 mg tablet

Placebo Comparator: Placebo

Henagliflozin 5Mg Tab DRUG

Single oral tablet

Active Comparator: Henagliflozin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Interventions

henagliflozin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Deyong Long

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

• Changsheng Ma

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

• Jianzeng Dong

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao Jiang, Dr

CONTACT

13811168422; superj@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiology

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: February 23, 2022
• Study Start: September 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: May 23, 2022

Record last verified: 2022-05

Locations

CN (1)