## Protocol Section
### Identification Module
**NCT ID:** NCT06433479

**Acronym:** DARE-AF

**Brief Title:** Efficacy of Dapagliflozin on Recurrence After Catheter Ablation for Atrial Fibrillation

**Official Title:** Efficacy of DApagliflozin on REcurrence After Catheter Ablation for Atrial Fibrillation

#### Organization Study ID Info
**ID:** 2024-4-20610
#### Organization
**Class:** OTHER
**Full Name:** Beijing Anzhen Hospital
### Status Module
#### Completion Date
**Date:** 2026-04-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-08-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Beijing Anzhen Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This is a single-center, parallel-group, randomized, open-label trial evaluating the effect of 3-month treatment with dapagliflozin 10mg once daily on the recurrence of atrial fibrillation after catheter ablation for atrial fibrillation in patients without diabetes, heart failure, or chronic kidney disease.

**Detailed Description:** Atrial fibrillation (AF) is one of the most common arrhythmias. Catheter ablation of atrial fibrillation, as the main means of rhythm control, can effectively maintain sinus rhythm, reduce the recurrence of AF burden, and improve the patient's quality of life and prognosis. However, AF recurrence still occurs in 30-50% of patients after atrial fibrillation catheter ablation, and there is currently no effective strategy to reduce the recurrence rate after atrial fibrillation ablation.

Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are a new class of diabetic drugs and large clinical trials have established their multiple cardiovascular benefits. Several studies demonstrated that SGLT2i might reduce AF/atrial flutter events among patients with diabetes. Our cohort study and meta-analysis demonstrated a lower risk of AF recurrence with the use of SGLT2i among patients with diabetes after AF ablation. However, the beneficial effects of SGLT2i in patients after AF catheter ablation without current indications for SGLT2i were uncertain.

In this study, we aim to evaluate the effect of dapagliflozin on AF burden. Patients with persistent AF undergoing initial catheter ablation without diabetes at high cardiovascular risk, heart failure, or chronic kidney disease will be enrolled. Patients will be randomly assigned to either the dapagliflozin group (10mg/d) for 3 months or the control group stratified according to body mass index (\<24, ≥24kg/m2) or left atrial diameter (\<45，≥45mm).

The primary outcome is atrial fibrillation burden calculated as the percentage of of all atrial arrhythmia episodes detected by 7-day single-lead ECG patches at 3 months after ablation. Quality of life and echocardiography changes of left atrial structure will also be evaluated at 3 months. Our central hypothesis is that SGLT2i will reduce the AF burden after catheter ablation.

### Conditions Module

**Conditions:**

- Atrial Fibrillation

**Keywords:**

- Catheter ablation

- Atrial fibrillation

- Recurrence

- Dapagliflozin

- AF Burden

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Dapagliflozin 10 mg per day for 3 months after initial catheter ablation

**Intervention Names:**

- Drug: Dapagliflozin 10 mg per day for 3 months after initial catheter ablation

**Label:** Dapagliflozin

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** No intervention

**Label:** Control

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Dapagliflozin

**Description:** Dapagliflozin 10 mg per day for 3 months after initial catheter ablation

**Name:** Dapagliflozin 10 mg per day for 3 months after initial catheter ablation

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Atrial fibrillation burden is defined as the percent of time spent in atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) episodes detected by 7-day single-lead ECG patches at 3 months after ablation.

**Measure:** Atrial fibrillation burden at 3 months after ablation

**Time Frame:** 3 months

#### Secondary Outcomes

**Description:** Atrial fibrillation recurrence is defined as the recurrence of any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) lasting 30 seconds or longer detected by 7-day single-lead ECG patches at 3 months after ablation.

**Measure:** Atrial fibrillation recurrence at 3 months after ablation

**Time Frame:** 3 months

**Description:** Changes of quality of life from baseline to 3 months after ablation evaluated by the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire.

**Measure:** Changes of quality of life at 3 months

**Time Frame:** 3 months

**Description:** Changes in the echocardiography parameter of anteroposterior atrial diameter from baseline to 3 months after ablation.

**Measure:** Echocardiography changes of left atrial structure at 3 months

**Time Frame:** 3 months

**Description:** Atrial fibrillation burden is defined as the percent of time spent in atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) episodes detected by 7-day single-lead ECG patches at 1 year after ablation.

**Measure:** Atrial fibrillation burden at 1 year after ablation

**Time Frame:** 1 year

**Description:** Atrial fibrillation recurrence is defined as the first recurrence of any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) lasting 30 seconds or longer detected by ECG during 1 year after ablation. In-person or telephonic follow-up visits will be scheduled at 3-, 6-, and 12-month post-procedure. At each time of follow-up, the following data will be collected: (1)7-day single-lead patch ECG and (2) symptom-triggered ECG since the last follow-up.

**Measure:** Atrial fibrillation recurrence during 1 year after ablation

**Time Frame:** 1 year

**Description:** The composite endpoint of cardiovascular death or cardiovascular hospitalization during 1-year follow-up.

**Measure:** Cardiovascular outcomes during 1-year follow-up

**Time Frame:** 1 year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. age between 18-80 years diagnosed with atrial fibrillation based on ECG or Holter
2. persistent atrial fibrillation
3. prepare to undergo initial catheter ablation for atrial fibrillation
4. agree to enrollment, randomization, treatment, and follow-up

Exclusion Criteria:

1. diagnosed with persistent atrial fibrillation longer than 5 years or left atrial anterior-posterior diameter ≥ 50mm
2. diagnosed with atrial fibrillation secondary to reversible causes (such as hyperthyroidism, acute infection, etc.)
3. severe structural heart disease (hypertrophic cardiomyopathy, rheumatic heart disease, dilated cardiomyopathy, etc.)
4. currently take sodium-glucose co-transporter 2 inhibitors
5. complicated with the following Class I indications for sodium-glucose co-transporter 2 inhibitors: i. patients with type 2 diabetes with atherosclerotic cardiovascular disease (ASCVD) or at high risk for ASCVD ii. patients with a history of heart failure (HF), including HF with reduced ejection fraction, mildly reduced ejection fraction, and preserved ejection fraction iii. patients with chronic kidney disease with eGFR=20-60 ml/min/1.73m2
6. complicated with the following contraindication of sodium-glucose co-transporter 2 inhibitors: i. with previous allergic reactions to dapagliflozin ii. with end-stage renal failure or dialysis
7. type 1 diabetes, or previous diabetic ketoacidosis
8. severe hypoglycemia or genitourinary infection in the past 12 months
9. hypovolemia or hypotension
10. currently enrolled in another clinical study.

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** superj@zju.edu.cn

**Name:** Chao Jiang, MD

**Phone:** +86 (010) 84005361

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** superj@zju.edu.cn

- **Name:** Chao Jiang

- **Phone:** 86+15001251357

- **Role:** CONTACT

***Contact 2:***

- **Name:** Zixu Zhao

- **Role:** SUB_INVESTIGATOR

***Contact 3:***

- **Name:** Zejun Yang

- **Role:** SUB_INVESTIGATOR

**Country:** China

**Facility:** Beijing Anzhen Hospital

**State:** Beijing

**Zip:** 100029

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001145

- Term: Arrhythmias, Cardiac

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000010335

- Term: Pathologic Processes

- ID: D000020969

- Term: Disease Attributes

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4586

- Name: Atrial Fibrillation

- Relevance: HIGH

- As Found: Atrial Fibrillation

- ID: M14850

- Name: Recurrence

- Relevance: HIGH

- As Found: Recurrence

- ID: M4453

- Name: Arrhythmias, Cardiac

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001281

- Term: Atrial Fibrillation

- ID: D000012008

- Term: Recurrence

### Intervention Browse Module - Ancestors

- ID: D000077203

- Term: Sodium-Glucose Transporter 2 Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000007004

- Term: Hypoglycemic Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M348449

- Name: Dapagliflozin

- Relevance: HIGH

- As Found: COPD

- ID: M1691

- Name: Sodium-Glucose Transporter 2 Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M10054

- Name: Hypoglycemic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000529054

- Term: Dapagliflozin

### Misc Info Module

- Version Holder: 2024-05-31
