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Henagliflozin in Patients With Atrial Fibrillation (HENA-AF)

Primary Purpose

Atrial Fibrillation

Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
placebo
Henagliflozin 5Mg Tab
Sponsored by
Beijing Anzhen Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Heart Failure, SGLT2i, Cardiac structure, Cardiac function

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Anzhen Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active Comparator: Henagliflozin

Placebo Comparator: Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Change in 6min walk test
Changes from baseline in 6min walk test in patients with AF treated with henagliflozin versus placebo.

Full Information

First Posted
January 11, 2022
Last Updated
May 17, 2022
Sponsor
Beijing Anzhen Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05252624
Brief Title
Henagliflozin in Patients With Atrial Fibrillation
Acronym
HENA-AF
Official Title
Impact of Henagliflozin on Cardiac Structure, Function and Biomarkers of Heart Failure in Patients With Persistent Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Anzhen Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Heart Failure, SGLT2i, Cardiac structure, Cardiac function

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Comparator: Henagliflozin
Arm Type
Active Comparator
Arm Description
Single 5 mg tablet, administered orally once daily for 6 months
Arm Title
Placebo Comparator: Placebo
Arm Type
Placebo Comparator
Arm Description
Single 5 mg tablet, administered orally once daily for 6 months
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo tablet manufactured to mimic henagliflozin 5 mg tablet
Intervention Type
Drug
Intervention Name(s)
Henagliflozin 5Mg Tab
Intervention Description
Single oral tablet
Primary Outcome Measure Information:
Title
Change in left atrial minimal volume index
Description
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 Outcome Measure Information:
Title
Atrial fibrillation quality of life
Description
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
Title
Change in left ventricular mass
Description
Changes from baseline in LV mass as measured by cardiac MR in patients with AF treated with henagliflozin versus placebo.
Time Frame
6 months
Title
Change in left ventricular end-diastolic volume index
Description
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
Title
Change in left ventricular end-systolic volume index
Description
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
Title
Change in left ventricular global longitudinal strain
Description
Changes from baseline in LV global longitudinal strain as measured by cardiac MR in patients with AF treated with henagliflozin versus placebo.
Time Frame
6 months
Title
Change in left ventricular ejection fraction
Description
Changes from baseline in LV ejection fraction as measured by cardiac MR in patients with AF treated with henagliflozin versus placebo.
Time Frame
6 months
Title
Change in extracellular volume
Description
Changes from baseline in extracellular volume (ECV) assessed using cardiac MR T1 mapping in patients with AF treated with henagliflozin versus placebo.
Time Frame
6 months
Title
Change in left atrial ejection fraction
Description
Changes from baseline in LA ejection fraction as measured by cardiac MR in patients with AF treated with henagliflozin versus placebo.
Time Frame
6 months
Title
Change in left atrial global longitudinal strain
Description
Changes from baseline in LA global longitudinal strain as measured by cardiac MR in patients with AF treated with henagliflozin versus placebo.
Time Frame
6 months
Title
Change in right ventricular mass
Description
Changes from baseline in RV mass as measured by cardiac MR in patients with AF treated with henagliflozin versus placebo.
Time Frame
6 months
Title
Change in right atrial volume index
Description
Changes from baseline in RA Volume Index as measured by cardiac MR in patients with AF treated with henagliflozin versus placebo.
Time Frame
6 months
Title
Change in biomarkers of heart failure
Description
Changes from baseline in biomarkers of heart failure (such as NT-proBNP) in patients with AF treated with henagliflozin versus placebo.
Time Frame
6 months
Title
Change in 6min walk test
Description
Changes from baseline in 6min walk test in patients with AF treated with henagliflozin versus placebo.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥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 Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chao Jiang, Dr
Phone
13811168422
Email
superj@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deyong Long
Organizational Affiliation
Beijing Anzhen Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Changsheng Ma
Organizational Affiliation
Beijing Anzhen Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jianzeng Dong
Organizational Affiliation
Beijing Anzhen Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Anzhen Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chao Jiang, MD
Phone
13811168422
Email
superj@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Henagliflozin in Patients With Atrial Fibrillation

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