Can a new drug stop long atrial fibrillation episodes?
NCT ID NCT07792239
First seen Aug 28, 2026 · Last updated Aug 28, 2026
Summary
This phase 2 trial tests budiodarone, an experimental drug, in about 100 people with non-permanent atrial fibrillation, especially the paroxysmal form. Researchers want to see if the drug can safely reduce or eliminate long episodes of irregular heartbeat that last five hours or more. Participants take budiodarone in increasing doses over 24 weeks while wearing monitors to track their heart rhythm. The study also measures how much the overall burden of atrial fibrillation changes during treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- budiodarone
- What this could lead to
- If it works, budiodarone could offer a new way to control atrial fibrillation and reduce the risk of long episodes that often lead to more serious complications.
- What could go wrong
- This is an early-phase trial with only 100 participants, so the drug may not prove effective or safe. Dose escalation could increase side effects, and results may not apply to all people with atrial fibrillation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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EMED Centrum Usług Medycznych Ewa Śmiałek
RECRUITINGRzeszów, 35-205, Poland
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Klinika Kardiologii
RECRUITINGKrakow, 30-901, Poland
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Klinika Kardiologii i Chorób Wewnętrznych Wojskowy Instytut Medyczny, Państwowy Instytut Badawczy
RECRUITINGWarsaw, 04-141, Poland
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Oddział Kardiologiczny, Szpital Miejski Św. Wincentego a Paulo w Gdyni
RECRUITINGGdynia, 81-348, Poland
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