Budiodarone for paroxysmal AF: a dose-escalation safety and feasibility study

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, multi-center, open-label trial evaluating budiodarone in people with non-permanent AF, especially paroxysmal AF. Participants start at 200 mg twice daily and may have their dose escalated every 4 weeks based on AF burden, assessed with implanted cardiac devices or wearables. The study uses a dose-escalation approach over 24 weeks to determine safety, tolerability, and preliminary efficacy, focusing on AF episodes lasting 5 hours or more. Eligible participants include those with a prior CIED, those undergoing electrical cardioversion, or those without a device but with frequent AF and qualifying CHA2DS2-VASc scores. Primary endpoints center on safety and feasibility of dose escalation with continuous AF monitoring.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Proven paroxysmal atrial fibrillation or undergoing first-time elective electrical (direct current) cardioversion for persistent atrial fibrillation, or second-time elective electrical (direct current) cardioversion.
* Baseline AF Criteria: To qualify for treatment, each participant must have during the 28-day baseline period an AFB greater than 5% and one of the following qualifying events: 1) 2 continuous AF episodes (LEAF) of 5 hours or longer; or 2) 2 rolling 24-hour periods in which cumulative AF duration is 5 hours or longer; or 3) 1 continuous AF episode (LEAF) of 5 hours or longer plus 1 rolling 24-hour period in which cumulative AF duration is 5 hours or longer
* Must have failed at least one prior therapy for AF
* Must have an AFSS greater than 3.
* CHA₂DS₂-VASc score of 1 or more for males and 2 or more for females and be on oral anticoagulant for at least 3 weeks prior to receiving the study medication.
* For participants with heart failure: NYHA Class I or II heart failure.

Key Exclusion Criteria:

* NYHA Class 3 or 4 heart failure.
* MI, ischemic stroke, or any clinically relevant venous thromboembolism within 3 months of screening.
* Unstable angina, percutaneous transluminal coronary angioplasty (PTCA), or CABG within 3 months of screening.
* Prolonged QTcF Interval with a normal QRS duration (\>500 ms with QRS ≤120 ms).
* Persistent AF (≥7 consecutive days or episodes \>23 hours). Those presenting with persistent AF at screening are eligible if they are scheduled to undergo first-time elective cardioversion, or second-time cardioversion
* Recent treatment with rhythm control medications (Class I or III Singh-Vaughan Williams) within five half-lives before screening (rate control drugs permitted) and amiodarone within 3 months prior to screening.
* Cardiac ablation procedures within 30 days of screening or participants who have scheduled an ablation procedure
* Severe end-organ disease

Where it's running

• Oddział Kardiologiczny, Szpital Miejski Św. Wincentego a Paulo w Gdyni
  Gdynia, Poland Recruiting
• Klinika Kardiologii
  Krakow, Poland Recruiting
• EMED Centrum Usług Medycznych Ewa Śmiałek
  Rzeszów, Poland Recruiting
• Klinika Kardiologii i Chorób Wewnętrznych Wojskowy Instytut Medyczny, Państwowy Instytut Badawczy
  Warsaw, Poland Recruiting

Study contacts

• Study coordinator: Frederic Heerinckx@xyra.us
• Email: fheerinckx@xyra.us
• Phone: +1 650 980-9972

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.