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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-ablation for 28 days

Awards & highlights

Study Summary

This trial is testing whether or not 2-HOBA can help reduce early recurrence of AF by binding to and inactivating IsoLG.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-ablation for 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-ablation for 28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-ablation for 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

Other outcome measures

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

American Heart AssociationOTHER

324 Previous Clinical Trials

4,933,679 Total Patients Enrolled

11 Trials studying Atrial Fibrillation

92,238 Patients Enrolled for Atrial Fibrillation

Vanderbilt University Medical CenterLead Sponsor

856 Previous Clinical Trials

672,093 Total Patients Enrolled

10 Trials studying Atrial Fibrillation

5,103 Patients Enrolled for Atrial Fibrillation

Greg Michaud, MDPrincipal InvestigatorVanderbilt University

Media Library

2-Hydroxybenzylamine (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04433091 — Phase 2

Atrial Fibrillation Research Study Groups: Placebo, 2-HOBA

Atrial Fibrillation Clinical Trial 2023: 2-Hydroxybenzylamine Highlights & Side Effects. Trial Name: NCT04433091 — Phase 2

2-Hydroxybenzylamine (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04433091 — Phase 2

Atrial Fibrillation Patient Testimony for trial: Trial Name: NCT04433091 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any patients needed to participate in this ongoing research?

"Unfortunately, this particular trial is not recruiting at the moment according to the latest update on clinicaltrials.gov (June 1st, 2022). Although this specific study is no longer looking for volunteers, there are still over 1500 other trials that need participants."

Answered by AI

How many individuals are being monitored as part of this research?

"Though this trial was posted on May 15th, 2020 and last updated June 1st, 2022, it is not currently recruiting patients. If you are interested in other studies, there are presently 1561 trials actively searching for participants with atrial fibrillation and 2 separate studies for 2-HOBA that need participants."

Answered by AI

What is the existing literature on 2-HOBA's efficacy?

"Currently, there are two ongoing studies involving 2-HOBA. However, neither of the active research projects are in Phase 3. Most of the clinical trials related to 2-HOBA take place in Nashville, Tennessee; although, there are also two other locations running similar experiments."

Answered by AI

Has 2-HOBA received any formalized acknowledgement from the FDA?

"Given that this is a phase 2 trial, and thus there is only limited data supporting its safety but none for efficacy, our team has given 2-HOBA a score of 2."

Answered by AI

Who else is applying?

What state do they live in?

Alabama

What site did they apply to?

Vanderbilt University Medical

What portion of applicants met pre-screening criteria?

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I have been on 3 different medications and nothing so far has worked consistently well. Side effects from several I have tried have significant side effects, so my medication options are getting smaller.

PatientReceived no prior treatments