Trial Outcomes & Findings for 2-Hydroxybenzylamine (2-HOBA) to Prevent Early Recurrence of Atrial Fibrillation After Catheter-based Ablation (NCT NCT04433091)

Last Updated: 2024-11-21

Results Overview

Participants will wear a smartwatch linked to an iPhone to continually record heart rate, variability and detection of arrhythmias. Participants will record a daily ECG each morning upon waking via the watch. In addition, participants will be notified by the smartwatch of 1) detection of atrial fibrillation or atrial flutter, 2) persistent high HR (\> 110 bpm) outside of exercise

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

95 participants

Primary outcome timeframe

Post-ablation through 28 days

Results posted on

2024-11-21

Participant Flow

Eligible subjects will be identified through EPIC. The study team will approach the patient in person in Arrhythmia Clinic or by phone prior to AF ablation. Information describing the study, will be provided. The risks and benefits will be described along with potential treatment advances. Informed consent will be obtained with the option of phone consent with electronic signature.

95 participants signed consent. 89 participants were randomized. 6 were withdrawn after enrollment and never randomized.

Participant milestones

Participant milestones
Measure	2-HOBA 2-Hydroxybenzylamine(2-HOBA) 250 mg three tabs TID (po) for seven days prior to ablation and 28 days post ablation. 2-Hydroxybenzylamine: 2-HOBA (2-Hydroxybenzlamine) 750mg will be given TID seven days prior to ablation and 28 days post ablation.	Placebo Placebo- three tabs TID (po) for seven days prior to ablation and 28 days post-ablation Placebo: Placebo will be given TID for seven days prior to ablation and 28 days post ablation.
Overall Study STARTED	46	43
Overall Study COMPLETED	43	39
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	2-HOBA 2-Hydroxybenzylamine(2-HOBA) 250 mg three tabs TID (po) for seven days prior to ablation and 28 days post ablation. 2-Hydroxybenzylamine: 2-HOBA (2-Hydroxybenzlamine) 750mg will be given TID seven days prior to ablation and 28 days post ablation.	Placebo Placebo- three tabs TID (po) for seven days prior to ablation and 28 days post-ablation Placebo: Placebo will be given TID for seven days prior to ablation and 28 days post ablation.
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawn .	2	4

Baseline Characteristics

2-Hydroxybenzylamine (2-HOBA) to Prevent Early Recurrence of Atrial Fibrillation After Catheter-based Ablation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	2-HOBA n=43 Participants 2-Hydroxybenzylamine(2-HOBA) 250 mg three tabs TID (po) for seven days prior to ablation and 28 days post ablation. 2-Hydroxybenzylamine: 2-HOBA (2-Hydroxybenzlamine) 750mg will be given TID seven days prior to ablation and 28 days post ablation.	Placebo n=39 Participants Placebo- three tabs TID (po) for seven days prior to ablation and 28 days post-ablation Placebo: Placebo will be given TID for seven days prior to ablation and 28 days post ablation.	Total n=82 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants	24 Participants n=7 Participants	51 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Age, Continuous	64 years n=5 Participants	63 years n=7 Participants	63 years n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	26 Participants n=7 Participants	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 Participants n=5 Participants	39 Participants n=7 Participants	82 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants	39 Participants n=7 Participants	82 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants	39 participants n=7 Participants	82 participants n=5 Participants

PRIMARY outcome

Timeframe: Post-ablation through 28 days

Outcome measures

Outcome measures
Measure	2-HOBA n=43 Participants 2-Hydroxybenzylamine(2-HOBA) 250 mg three tabs TID (po) for seven days prior to ablation and 28 days post ablation. 2-Hydroxybenzylamine: 2-HOBA (2-Hydroxybenzlamine) 750mg will be given TID seven days prior to ablation and 28 days post ablation.	Placebo n=39 Participants Placebo- three tabs TID (po) for seven days prior to ablation and 28 days post-ablation Placebo: Placebo will be given TID for seven days prior to ablation and 28 days post ablation.
Number of Patients Atrial Fibrillation	26 Participants	14 Participants

SECONDARY outcome

Timeframe: Pre-ablation and Post-procedure day #1

Population: This outcome required blood draw collections 1 day post ablation. During the Covid pandemic, this became impractical on approx. half the patients. IsoLG levels were only collected and analyzed on patients for whom blood samples were available.

Circulating IsoLG adducts can be measured in the blood at different periods of time.

Outcome measures

Outcome measures
Measure	2-HOBA n=23 Participants 2-Hydroxybenzylamine(2-HOBA) 250 mg three tabs TID (po) for seven days prior to ablation and 28 days post ablation. 2-Hydroxybenzylamine: 2-HOBA (2-Hydroxybenzlamine) 750mg will be given TID seven days prior to ablation and 28 days post ablation.	Placebo n=22 Participants Placebo- three tabs TID (po) for seven days prior to ablation and 28 days post-ablation Placebo: Placebo will be given TID for seven days prior to ablation and 28 days post ablation.
The Change in IsoLG-adducts Levels From AF Pre-ablation to Post-procedure Day #1	3.37 percentage of IsoLG in circ. monocytes Interval 0.86 to 27.8	4.52 percentage of IsoLG in circ. monocytes Interval 0.9 to 38.5

SECONDARY outcome

Timeframe: 28 days post ablation

Population: The Apple Watch tracings were available to adjudicate recurrence in the final study cohort. However, burden required more data collection. Two of the participants were unable to provide the data. 1 participant refused. Outcome measure three part B required blood draw collections 1 day post ablation. During the Covid pandemic, this became impractical on \~half the patients. Outcome measure B (isoLG levels) were only collected and analyzed on patients for whom blood samples were available

AF burden obtained from smartwatch as defined by the percentage of time in AF compared to the time the smartwatch was worn.

Outcome measures

Outcome measures
Measure	2-HOBA n=42 Participants 2-Hydroxybenzylamine(2-HOBA) 250 mg three tabs TID (po) for seven days prior to ablation and 28 days post ablation. 2-Hydroxybenzylamine: 2-HOBA (2-Hydroxybenzlamine) 750mg will be given TID seven days prior to ablation and 28 days post ablation.	Placebo n=36 Participants Placebo- three tabs TID (po) for seven days prior to ablation and 28 days post-ablation Placebo: Placebo will be given TID for seven days prior to ablation and 28 days post ablation.
Exploratory Secondary Outcome	0 percentage of time in AF Interval 0.0 to 0.007	0 percentage of time in AF Interval 0.0 to 0.0

Adverse Events

2-HOBA

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	2-HOBA n=43 participants at risk 2-Hydroxybenzylamine(2-HOBA) 250 mg three tabs TID (po) for seven days prior to ablation and 28 days post ablation. 2-Hydroxybenzylamine: 2-HOBA (2-Hydroxybenzlamine) 750mg will be given TID seven days prior to ablation and 28 days post ablation.	Placebo n=39 participants at risk Placebo- three tabs TID (po) for seven days prior to ablation and 28 days post-ablation Placebo: Placebo will be given TID for seven days prior to ablation and 28 days post ablation.
Gastrointestinal disorders nausea	7.0% 3/43 • First 28 days Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, only if it was considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.	12.8% 5/39 • First 28 days Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, only if it was considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.
Nervous system disorders Headache	0.00% 0/43 • First 28 days Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, only if it was considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.	5.1% 2/39 • First 28 days Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, only if it was considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.

Additional Information

M.Benjamin Shoemaker,MD MSCI

Vanderbilt University Medical Center

Phone: 615-322-2318

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place