Atrial Fibrillation (AF)Phase 2Harbor-AFNCT07792239
Dose Escalation Study to Assess Safety, Tolerability, and Efficacy of Budiodarone Treatment With Non-permanent Atrial Fibrillation
A Phase 2 study testing Budiodarone 200 mg BID, Budiodarone 400 mg BID and Budiodarone 600 mg BID in people with Atrial Fibrillation (AF) and Paroxysmal AF, run by Xyra, LLC at 4 sites in Poland.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation (AF), Paroxysmal AF
- What is being tested?
- Budiodarone 200 mg BID, Budiodarone 400 mg BID and Budiodarone 600 mg BID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesPoland
- Study dates
- 6 Aug 2026to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland4 sites, 4 recruiting
- Recruiting
Oddział Kardiologiczny, Szpital Miejski Św. Wincentego a Paulo w Gdyni
Gdynia, 81-348
Frederic Heerinckx, +1 650 980-9972, fheerinckx@xyra.us
- Recruiting
Klinika Kardiologii
Krakow, 30-901
Frederic Heerinckx, +1 650 980-9972, fheerinckx@xyra.us
- Recruiting
EMED Centrum Usług Medycznych Ewa Śmiałek
Rzeszów, 35-205
Frederic Heerinckx, +1 650 980-9972, fheerinckx@xyra.us
- Recruiting
Klinika Kardiologii i Chorób Wewnętrznych Wojskowy Instytut Medyczny, Państwowy Instytut Badawczy
Warsaw, 04-141
Frederic Heerinckx, +1 650 980-9972, fheerinckx@xyra.us
About this study
Official title: 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.
Read the detailed description
The study will allow AF participants from three specific populations: 1) Participants with a pre-implanted Cardiac Implantable Electrical Device (CIED), which includes implantable pacemakers or implantable loop recorders (ILR) and who have a history of paroxysmal AF with LEAF lasting 5 hours or longer recorded in their pacemaker within the 3 months before screening; 2) Participants undergoing first-time elective electrical (direct current) cardioversion for persistent AF, or second-time elective electrical (direct current) cardioversion; and 3) Participants with paroxysmal AF who do not have a pacemaker or ILR and who have a history of frequent AF and LEAF, with a minimum CHA2DS2-VASc score of 1 or more for males and 2 or more for females.
AF monitoring will be conducted via a pre-implanted Cardiac Implantable Electrical Device (CIED), which includes implantable pacemakers or implantable loop recorders (ILR), for those who have one. Participants without a CIED will undergo AF monitoring using a cardiac patch and/or a wearable device on the wrist.
All participants who meet the study entry criteria will be started on 200 mg budiodarone BID. The participants will return to the study site every 4 weeks and dose adjustments will follow the following algorithm. If no AF episode lasting 5 hours or longer is recorded and no rolling 24-hour period shows a cumulative AF burden of 5 hours or longer, the participant is classified as a monthly responder, and the budiodarone dose remains unchanged. If at least one AF episode of 5 hours or longer is observed, or if any rolling 24-hour period indicates a cumulative AF burden of 5 hours or longer, the participant is designated as a monthly non-responder, and the budiodarone dose is increased by 200 mg BID up to a maximum of 800 mg BID.
- Conditions
- Atrial Fibrillation (AF), Paroxysmal AF
- Being tested
- Budiodarone 200 mg BID, Budiodarone 400 mg BID, Budiodarone 600 mg BID, Budiodarone 800 mg BID
- Keywords
- AF, Atrial Fibrillation, Paroxysmal Atrial Fibrillation, PAF
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budiodarone 200 mg BIDDrug
Budiodarone is formulated as 200 mg capsules, to be administered as 1 capsule (200mg) twice a day (BID).
Budiodarone 400 mg BIDDrug
Budiodarone is formulated as 200 mg capsules, to be administered as 2 capsules (400 mg) BID.
Budiodarone 600 mg BIDDrug
Budiodarone is formulated as 200 mg capsules, to be administered as 3 capsules (600 mg) BID.
Budiodarone 800 mg BIDDrug
Budiodarone is formulated as 200 mg capsules, to be administered as 4 capsules (800 mg) BID.
| Study group | Role | What they receive |
|---|---|---|
| Budiodarone | Experimental | Budiodarone is formulated as 200 mg capsules, to be administered as 1 capsule (200mg) twice a day (BID), 2 capsules (400 mg) BID, 3 capsules (600 mg) BID or 4 capsules (800 mg) BID. Receives: Drug: Budiodarone 200 mg BID; Drug: Budiodarone 400 mg BID; Drug: Budiodarone 600 mg BID; Drug: Budiodarone 800 mg BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants that have no long episodes of atrial fibrillation (LEAF) in the final month of treatment
Proportion of participants that have no LEAF (uninterrupted episode of AF of 5 hours or longer in duration or cumulative duration of AF in any rolling 24-hour period that is 5 hours or longer) in the final month of treatment.
Measured: 24 weeks
Secondary outcomes (3)
Percent Change in Atrial Fibrillation Burden (AFB)
Percent change in AFB during final month of treatment compared to baseline.
Measured: 24 weeks
Change in percent of Atrial Fibrillation Severity Scale (AFSS) during final month of treatment.
The University of Toronto Atrial Fibrillation Severity Scale (AFSS) is a patient-reported outcome instrument developed to quantify atrial fibrillation (AF). In this study, Part C of the scale will be used. In Part C, participants are asked to asses how AF symptoms affect daily activities, physical functioning, and overall quality of life. The minimum score is 0 and the maximum score is 35. Higher scores reflect greater impairment from AF-related symptoms. AFSS score during final month of treatment will be compared to baseline for multiple doses of budiodarone.
Measured: 24 weeks
Patient Global Impression of Change (PGI-C) during the final month of treatment
The Patient Global Impression of Change (PGI-C) is a two-question instrument that employs a Likert scale to assess participants' perceived changes in AF symptom control and overall satisfaction. Response options for symptom control include: Made them worse, No change, Slight improvement, Moderate improvement, A lot of improvement, and Complete relief. For overall satisfaction, participants choose from: Not at all, A little bit, Somewhat, A lot, and Completely.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start6 Aug 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants who meet the study entry criteria will be started on 200 mg budiodarone BID. The participants will return to the study site every 4 weeks and dose adjustments will follow the following algorithm. If no AF episode lasting 5 hours or longer is recorded and no rolling 24-hour period shows a cumulative AF burden of 5 hours or longer, the participant is classified as a monthly responder, and the budiodarone dose remains unchanged. If at least one AF episode of 5 hours or longer is observed, or if any rolling 24-hour period indicates a cumulative AF burden of 5 hours or longer, the participant is designated as a monthly non-responder, and the budiodarone dose is increased by 200 mg BID up to a maximum of 800 mg BID.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xyra, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amarex Clinical Research
- Responsible party
- Sponsor
- Investigators
- Peter G Milner, MD, FACC, Study director, Xyra, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792239
- Sponsor's protocol ID
- CLN-209
- Other IDs
- 2025-523860-19-00, 2025
- Acronym
- Harbor-AF
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07792239
- Acronym / sponsor ID
- Harbor-AF / CLN-209
- Conditions
- Atrial Fibrillation (AF), Paroxysmal AF
- Keywords
- AF, Atrial Fibrillation, Paroxysmal Atrial Fibrillation, PAF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xyra, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Amarex Clinical Research
- Study start
- 6 Aug 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will allow AF participants from three specific populations: 1) Participants with a pre-implanted Cardiac Implantable Electrical Device (CIED), which includes implantable pacemakers or implantable loop recorders (ILR) and who have a history of paroxysmal AF with LEAF lasting 5 hours or longer recorded in their pacemaker within the 3 months before screening; 2) Participants undergoing first-time elective electrical (direct current) cardioversion for persistent AF, or second-time elective electrical (direct current) cardioversion; and 3) Participants with paroxysmal AF who do not have a pacemaker or ILR and who have a history of frequent AF and LEAF, with a minimum CHA2DS2-VASc score of 1 or more for males and 2 or more for females.
AF monitoring will be conducted via a pre-implanted Cardiac Implantable Electrical Device (CIED), which includes implantable pacemakers or implantable loop recorders (ILR), for those who have one. Participants without a CIED will undergo AF monitoring using a cardiac patch and/or a wearable device on the wrist.
All participants who meet the study entry criteria will be started on 200 mg budiodarone BID. The participants will return to the study site every 4 weeks and dose adjustments will follow the following algorithm. If no AF episode lasting 5 hours or longer is recorded and no rolling 24-hour period shows a cumulative AF burden of 5 hours or longer, the participant is classified as a monthly responder, and the budiodarone dose remains unchanged. If at least one AF episode of 5 hours or longer is observed, or if any rolling 24-hour period indicates a cumulative AF burden of 5 hours or longer, the participant is designated as a monthly non-responder, and the budiodarone dose is increased by 200 mg BID up to a maximum of 800 mg BID.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants who meet the study entry criteria will be started on 200 mg budiodarone BID. The participants will return to the study site every 4 weeks and dose adjustments will follow the following algorithm. If no AF episode lasting 5 hours or longer is recorded and no rolling 24-hour period shows a cumulative AF burden of 5 hours or longer, the participant is classified as a monthly responder, and the budiodarone dose remains unchanged. If at least one AF episode of 5 hours or longer is observed, or if any rolling 24-hour period indicates a cumulative AF burden of 5 hours or longer, the participant is designated as a monthly non-responder, and the budiodarone dose is increased by 200 mg BID up to a maximum of 800 mg BID.
| Arm | Type | Receives |
|---|---|---|
| Budiodarone | Experimental | Drug: Budiodarone 200 mg BID, Drug: Budiodarone 400 mg BID, Drug: Budiodarone 600 mg BID, Drug: Budiodarone 800 mg BIDBudiodarone is formulated as 200 mg capsules, to be administered as 1 capsule (200mg) twice a day (BID), 2 capsules (400 mg) BID, 3 capsules (600 mg) BID or 4 capsules (800 mg) BID. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budiodarone 200 mg BIDBudiodarone is formulated as 200 mg capsules, to be administered as 1 capsule (200mg) twice a day (BID). | Drug | Budiodarone |
| Budiodarone 400 mg BIDBudiodarone is formulated as 200 mg capsules, to be administered as 2 capsules (400 mg) BID. | Drug | Budiodarone |
| Budiodarone 600 mg BIDBudiodarone is formulated as 200 mg capsules, to be administered as 3 capsules (600 mg) BID. | Drug | Budiodarone |
| Budiodarone 800 mg BIDBudiodarone is formulated as 200 mg capsules, to be administered as 4 capsules (800 mg) BID. | Drug | Budiodarone |
Primary outcome
Proportion of participants that have no long episodes of atrial fibrillation (LEAF) in the final month of treatment
Time frame: 24 weeks
Proportion of participants that have no LEAF (uninterrupted episode of AF of 5 hours or longer in duration or cumulative duration of AF in any rolling 24-hour period that is 5 hours or longer) in the final month of treatment.
3 secondary outcomes
Percent Change in Atrial Fibrillation Burden (AFB)
Time frame: 24 weeks
Change in percent of Atrial Fibrillation Severity Scale (AFSS) during final month of treatment.
Time frame: 24 weeks
Patient Global Impression of Change (PGI-C) during the final month of treatment
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter G Milner, MD, FACC study director
Xyra, LLC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Budiodarone 200 mg BID, Budiodarone 400 mg BID and Budiodarone 600 mg BID in people with Atrial Fibrillation (AF) and Paroxysmal AF, run by Xyra, LLC at 4 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frederic Heerinckx@xyra.us (+1 650 980-9972, fheerinckx@xyra.us), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants that have no long episodes of atrial fibrillation (LEAF) in the final month of treatment (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.