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Dose Escalation Study to Assess Safety, Tolerability, and Efficacy of Budiodarone Treatment With Non-permanent Atrial Fibrillation

Name: Dose Escalation Study to Assess Safety, Tolerability, and Efficacy of Budiodarone Treatment With Non-permanent Atrial Fibrillation — clinical trial record (NCT07792239)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: Harbor-AF

StatusRecruiting

PhasePhase 2

SponsorXyra, LLC

Started2026-08-06

View on ClinicalTrials.gov ↗

This multicenter, open-label study aims to assess the safety, tolerability and efficacy of budiodarone in treating participants with non-permanent AF, in particular paroxysmal atrial fibrillation (PAF). The trial will serve as a 6-month safety and a proof-of-concept study for a dose escalation strategy using AF monitoring, enrolling approximately 100 participants who will undergo 24 weeks of treatment. The study aims to evaluate the feasibility of dose escalation through AF monitoring of long episodes atrial fibrillation last 5 hours or longer.

Trial Details

NCT Number	NCT07792239
Lead Sponsor	Xyra, LLC Collaborators: Amarex Clinical Research
Conditions	Atrial Fibrillation (AF), Paroxysmal AF
Enrollment	100 participants
Start Date	2026-08-06
Primary Completion	2027-06-30 (estimated)
Study Completion	2027-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-08-28