## Protocol Section
### Identification Module
**NCT ID:** NCT04155879

**Brief Title:** Atrial Fibrillation Recurrence Following Cardioversion: the Role of Clinical Factors and Alpha Defensin Levels

**Official Title:** Atrial Fibrillation Recurrence Following Cardioversion: the Role of Clinical Factors and Alpha Defensin Levels

#### Organization Study ID Info
**ID:** HYMC-19-0074
#### Organization
**Class:** OTHER_GOV
**Full Name:** Hillel Yaffe Medical Center
### Status Module
#### Completion Date
**Date:** 2022-11

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2019-11-07

**Type:** ACTUAL

**Last Update Submit Date:** 2019-11-06

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2022-11

**Type:** ESTIMATED

#### Start Date
**Date:** 2019-11

**Type:** ESTIMATED

**Status Verified Date:** 2019-11

#### Study First Post Date
**Date:** 2019-11-07
**Type:** ACTUAL
**Study First Submit Date:** 2019-09-11
**Study First Submit QC Date:** 2019-11-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Hillel Yaffe Medical Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Atrial fibrillation and inflammation are strongly correlated. The aim of this study is to evaluate whether inflammation markers (alpha Defensin) predict maintenance of sinus rhythm following cardioversion. A secondary aim is to evaluate the role of Colchicine, an anti-inflammatory medication, in reducing the recurrence rate of atrial fibrillation.

### Conditions Module

**Conditions:**

- Atrial Fibrillation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** Investigator and participants will be blinded regarding levels of anti-inflammatory markers

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 300

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Cardioversion without treatment with Colchicine

**Label:** Control Group

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** This arm will undergo cardioversion followed by Colchicine (0.5 mg 2x per day) for six months

**Intervention Names:**

- Drug: Colchicine Tablets

- Procedure: Cardioversion

**Label:** Treatment group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Treatment group

**Description:** Administration of Colchicine at a dose of 0.5mg 2x a day for six months.

**Name:** Colchicine Tablets

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Treatment group

**Description:** Electrical or pharmacologic restoration of sinus rhythm

**Name:** Cardioversion

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Atrial fibrillation recurrence rates over the next 12 months will be determined based on medical records and ECG documentation between treatment group (Colchicine) and control group.

**Measure:** Recurrence of atrial fibrillation

**Time Frame:** 12 months

#### Secondary Outcomes

**Description:** Alpha Defensin levels will be measured in patients with recurrence of atrial fibrillation and compared to levels in patients without recurrence.

**Measure:** Alpha Defensin levels in patients with recurrence of atrial fibrillation

**Time Frame:** 12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Atrial fibrillation
* Candidate for cardioversion

Exclusion Criteria:

* Colchicine allergy
* Hepatic or renal failure

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** asdanon@gmail.com

**Name:** Asaf Danon, MD, MSC

**Phone:** 972-55-8867102

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hadera

**Contacts:**

***Contact 1:***

- **Email:** asdanon@gmail.com

- **Name:** Asaf Danon, MD, MSC

- **Phone:** 972-55-8867102

- **Role:** CONTACT

**Country:** Israel

**Facility:** Hillel Yaffe Medical Center

**Zip:** 38100

### 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: D000006074

- Term: Gout Suppressants

- ID: D000018501

- Term: Antirheumatic Agents

- ID: D000050257

- Term: Tubulin Modulators

- ID: D000050256

- Term: Antimitotic Agents

- ID: D000050258

- Term: Mitosis Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

### Intervention Browse Module - Browse Leaves

- ID: M6307

- Name: Colchicine

- Relevance: HIGH

- As Found: Positron

- ID: M22859

- Name: Defensins

- Relevance: LOW

- As Found: Unknown

- ID: M22861

- Name: alpha-Defensins

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M26197

- Name: Tubulin Modulators

- Relevance: LOW

- As Found: Unknown

- ID: M26196

- Name: Antimitotic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000003078

- Term: Colchicine

### Misc Info Module

- Version Holder: 2024-05-24
