Budiodarone at rising doses for people with non-permanent atrial fibrillation
Tests budiodarone at increasing doses in adults with paroxysmal or non-permanent atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Dose Escalation Study to Assess Safety, Tolerability, and Efficacy of Budiodarone Treatment With Non-permanent Atrial Fibrillation
Key facts
- Where
- Bialystok, Cracow, Czeladz, Gdynia, Katowice, Lodz, Opole, Przemyśl, Rzeszów, and Warsaw, PolandSee the 14 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07792239, who can take part
Where in Poland
- Uniwersytecki Szpital Kliniczny w BialymstokuBialystok, PolandTaking people
- 5 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej W KrakowieCracow, PolandTaking people
- Unicardia Specjalistyczne Centrum Leczenia Chorob Serca I Naczyn & Unimedica Specjalistyczne Centrum Medyczne & Uniestetica Centrum Chirurgii Plastycznej Rekonstrukcyjnej I Medycyny Estetycznej Malopolskie Kliniki Specjalistyczne Sp. z o.o.Cracow, PolandTaking people
- Centrum-Med Anna Drzewiecka Elzbieta Drzewiecka Sp. j.Czeladz, PolandTaking people
- Szpitale Pomorskie Sp z o oGdynia, PolandTaking people
- Revital Gabinet Kardiologiczny K. Golba J. Biernat Sp. j.Katowice, PolandTaking people
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w LodziLodz, PolandTaking people
- Uniwersytecki Szpital Kliniczny w OpoluOpole, PolandTaking people
- Wojewodzki Szpital im Sw Ojca Pio w PrzemysluPrzemyśl, PolandTaking people
- EMED Centrum Uslug Medycznych Ewa SmialekRzeszów, PolandTaking people
- Balsammedica Sp. z o. o.Warsaw, PolandTaking people
- Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut BadawczyWarsaw, PolandTaking people
- Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.Warsaw, PolandTaking people
- Wojskowy Instytut Medyczny Panstwowy Instytut BadawczyWarsaw, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xyra, LLC
- Trial code
- NCT07792239EU 2025-523860-19-00
- Record updated
- 28 August 2026
- Original description
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.Read full original descriptionShow less
A Multicenter, Open-Label, Dose Escalation Study of the Safety, Tolerability, and Efficacy of Budiodarone for the Treatment of Subjects With Non-permanent Atrial Fibrillation
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.
Inclusion: 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.
Exclusion: 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; 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; Cardiac ablation procedures within 30 days of screening or participants who have scheduled an ablation procedure; Severe end-organ disease; 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.