What side effects are associated with this type of intervention?

Common treatments for Atrial Fibrillation (AF) include antiarrhythmic drugs such as dronedarone, flecainide, propafenone, and amiodarone. Dronedarone has been associated with an increased risk of cardiovascular events, including stroke, myocardial infarction, and heart failure. Flecainide and propafenone are effective but should not be used in patients with structural heart disease due to the risk of proarrhythmia. Amiodarone, while effective, can cause thyroid dysfunction, pulmonary toxicity, and liver enzyme abnormalities. These treatments require careful monitoring to manage potential side effects and ensure patient safety.

What prior FDA approvals exist?

The FDA has approved several treatments for Atrial Fibrillation, primarily focusing on anticoagulants and antiarrhythmic drugs. Anticoagulants like warfarin and direct oral anticoagulants (DOACs) such as dabigatran, rivaroxaban, and apixaban are commonly used to prevent stroke in AF patients. Antiarrhythmic drugs like amiodarone, sotalol, and dronedarone help maintain normal heart rhythm. While these treatments manage symptoms and reduce complications, they do not specifically target oxidative stress-related tissue injury like 2-HOBA, which is being studied for its potential to inactivate IsoLGs and prevent early recurrence of AF post-ablation.

What other types of research exist?

Promising alternatives to 2-HOBA for Atrial Fibrillation patients include (-)epigallocatechin gallate (EGCG), Ginkgo biloba extract (EGb 761), and α-Iso-cubebene (ICB). These compounds have shown cardioprotective and antioxidant effects in experimental studies, potentially offering benefits in reducing oxidative stress-related tissue injury.

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2-HOBA for Atrial Fibrillation Recurrence

Phase 2

Waitlist Available

Led By Greg Michaud, MD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

First time AF ablation with radiofrequency or cryo ablation

22 years of age or older

Must not have

Amiodarone within past 3 months

Planned surgical or hybrid (surgical + catheter) ablation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-ablation for 28 days

Summary

This trial is testing whether a new treatment can help patients with atrial fibrillation (AF) who are undergoing a heart procedure called ablation. The goal is to see if this treatment can prevent early recurrence of AF by neutralizing harmful substances released during the procedure. The study will use smartwatches to monitor heart activity and measure the effectiveness of the treatment.

Who is the study for?

This trial is for adults aged 22 or older who are undergoing their first catheter-based ablation for atrial fibrillation, or a repeat procedure if they have persistent AF. Participants must be able to consent in writing and not have used certain medications like amiodarone recently, nor should they have severe heart failure, kidney issues, life expectancy under one year, or be pregnant.

What is being tested?

The study tests whether taking the antioxidant compound 2-Hydroxybenzylamine (2-HOBA) before an ablation can prevent early recurrence of atrial fibrillation by reducing oxidative stress. Patients will either receive 2-HOBA or a placebo starting seven days before the procedure. The effectiveness will be monitored daily using smartwatch ECG recordings.

What are the potential side effects?

While specific side effects of 2-HOBA aren't detailed here, participants might experience typical reactions associated with supplements such as digestive discomfort. Any medication could potentially cause allergic reactions or interact with existing conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am having my first AF ablation using either radiofrequency or cryo.

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I am 22 years old or older.

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I need another AF ablation because my atrial fibrillation persists and the doctor plans to target areas outside the pulmonary veins.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not taken Amiodarone in the last 3 months.

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I am scheduled for a surgery that involves removing or destroying tissue.

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I have severe heart failure.

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I have a condition like rheumatoid arthritis or psoriasis.

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I am currently taking oral steroids or colchicine.

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I have not had heart or chest surgery in the last 6 months.

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I have had or am planning to have a heart transplant.

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I am currently taking MAO inhibitors.

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I have active heart-related chest pain.

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I have been diagnosed with Hypertrophic Cardiomyopathy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-ablation.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-ablation.

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-ablation. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

2-HOBA reduces the rate of early recurrence of AF, atrial tachycardia, or atrial flutter following AF ablation within 28 days follow-up

A secondary analysis will analyze a surrogate of AF burden as the endpoint and designed to account for the impact of cardioversion on AF burden assessment

Secondary study objectives

2-HOBA reduces the change in IsoLG-adduct levels that occurs with AF ablation.

Other study objectives

Atrial Fibrillation

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: 2-HOBAActive Control1 Intervention

2-Hydroxybenzylamine(2-HOBA) 250 mg three tabs TID (po) for seven days prior to ablation and 28 days post ablation.

Group II: PlaceboPlacebo Group1 Intervention

Placebo- three tabs TID (po) for seven days prior to ablation and 28 days post-ablation

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Atrial Fibrillation (AF) include anticoagulants, antiarrhythmic drugs, and catheter ablation. Anticoagulants, such as warfarin and direct oral anticoagulants (DOACs), prevent blood clots and reduce the risk of stroke by inhibiting clotting factors. Antiarrhythmic drugs, like amiodarone and flecainide, work by stabilizing the electrical activity of the heart to maintain a regular rhythm. Catheter ablation targets and destroys small areas of heart tissue that cause irregular electrical signals. The trial studying 2-HOBA focuses on preventing oxidative stress-related tissue injury by inactivating IsoLGs, which could reduce early recurrence of AF post-ablation. This is important for AF patients as it addresses a specific cause of AF recurrence, potentially improving long-term outcomes and reducing the need for repeated interventions.

Does prophylactic therapy with antioxidant vitamins have an effect on atrial fibrillation following cardiac surgery?