Back to results

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

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:

≥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

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

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

NCT ID

NCT05252624

First Posted

January 11, 2022

Last Updated

May 17, 2022

Sponsor

Beijing Anzhen Hospital

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

Studies a U.S. FDA-regulated Device Product

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

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

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

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

superj@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Henagliflozin in Patients With Atrial Fibrillation

We'll reach out to this number within 24 hrs