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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
EU CTIS ID: 2025-523860-19-00
What this study is testing
To evaluate the safety and tolerability of budiodarone To evaluate the occurrence of treatment emergent adverse events (TEAE), serious adverse events (SAE) and adverse events of special interest (AESI) which includes the examples of major adverse cardiac events (MACE) To evaluate the efficacy of Budiodarone to prevent LEAF in subjects with non-permanent AF.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- CIED (Pacemaker or implantable loop recorder) Population o Participants with a history of paroxysmal AF with LEAF lasting more than 5 hours recorded in their pacemaker within the 3 months before screening. o The CIED data will be used to assess baseline AF eligibility criteria
- Prior Therapy: Must have failed at least one prior therapy for AF including: • Prior AAD based upon physician judgement • Prior rate control drugs based upon physician judgement and continued symptoms • AF catheter ablation
- AFSS: 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.
- NYHA Class I or II heart failure. However, those with NYHA Class II heart failure or a documented ejection fraction (EF) below 45% within the past two years must complete additional assessments
- Able to understand study requirements and willing to follow instructions, attend all required study visits, and undergo all planned tests.
You likely can't join if
- Pregnancy/Contraception: Pregnant women, women intending to become pregnant, or women not practicing effective contraception (pharmacological or barrier methods).
- Presence or history of congenital or primary cardiac channelopathies. This includes, but is not limited to: a. Congenital Long QT Syndrome (LQTS), including: i. Romano–Ward syndrome (autosomal dominant LQTS) ii. Jervell and Lange–Nielsen syndrome (autosomal recessive LQTS with sensorineural deafness) iii. Andersen–Tawil syndrome (LQT7; KCNJ2 mutation) iv. Timothy syndrome (LQT8; CACNA1C mutation) b. Brugada syndrome (SCN5A-related sodium channelopathy) c. Short QT syndrome d. Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT; RyR2 or CASQ2 mutations) e. Long–Ganong–Levine syndrome f. Wolff–Parkinson–White syndrome or any form of pre-excitation due to an accessory pathway
- Third-degree Atrioventricular Block without a functioning pacemaker.
- Advanced His-Purkinje system disease or bifascicular block associated with syncope or presyncope without a functioning pacemaker.
- Prior history of sustained ventricular tachycardia without an AICD or Torsades de Pointes.
- Reversible causes of AF (e.g., hyperthyroidism, recent open- heart surgery, metabolic or electrolyte shift, or ongoing active ischemia).
See the full eligibility criteria
Who can join
- CIED (Pacemaker or implantable loop recorder) Population o Participants with a history of paroxysmal AF with LEAF lasting more than 5 hours recorded in their pacemaker within the 3 months before screening. o The CIED data will be used to assess baseline AF eligibility criteria
- Prior Therapy: Must have failed at least one prior therapy for AF including: • Prior AAD based upon physician judgement • Prior rate control drugs based upon physician judgement and continued symptoms • AF catheter ablation
- AFSS: 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.
- NYHA Class I or II heart failure. However, those with NYHA Class II heart failure or a documented ejection fraction (EF) below 45% within the past two years must complete additional assessments
- Able to understand study requirements and willing to follow instructions, attend all required study visits, and undergo all planned tests.
- Elective Cardioversion Population (Persistent AF) o Participants undergoing first-time elective cardioversion for persistent AF, or second-time cardioversion and no antiarrhythmic concomitant drugs (or who wash out) and who are on stable DOAC for at least 3 weeks and who do not require a TEE to rule out thrombus.
- PAF Population Without Pacemakers or ILR where AF is quantified with wearable bands / patches o 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 and are on oral anticoagulant for at least 3 weeks prior to receiving the study medication. o The patch data will be used to assess baseline AF eligibility criteria
- Age: Adults between 18 and 80 years old.
- Informed Consent: Must be capable and willing to provide written IC.
- Women: Either postmenopausal for at least one year or surgically sterile; if premenopausal, must agree to use an approved method of contraception
- Men: Must agree to use an approved method of contraception, such as condoms with spermicide, or have a sterile partner, throughout the 12-week treatment period
- Proven paroxysmal atrial fibrillation (ECG, Holter monitor, cardiac patch, wearable or pacemaker diagnosis obtained by the clinical site or patient’s prior medical record documenting clear evidence of a diagnosis of PAF) or undergoing first-time elective cardioversion for persistent atrial fibrillation, or second-time cardioversion and no antiarrhythmic concomitant drugs (or who wash out) and who are on stable DOAC for at least 3 weeks and who do not require a TEE to rule out thrombus.
- 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: • 2 continuous AF episodes (LEAF) of 5 hours or longer • 2 rolling 24-hour periods in which cumulative AF duration is 5 hours or longer • 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
What rules you out
- Pregnancy/Contraception: Pregnant women, women intending to become pregnant, or women not practicing effective contraception (pharmacological or barrier methods).
- Presence or history of congenital or primary cardiac channelopathies. This includes, but is not limited to: a. Congenital Long QT Syndrome (LQTS), including: i. Romano–Ward syndrome (autosomal dominant LQTS) ii. Jervell and Lange–Nielsen syndrome (autosomal recessive LQTS with sensorineural deafness) iii. Andersen–Tawil syndrome (LQT7; KCNJ2 mutation) iv. Timothy syndrome (LQT8; CACNA1C mutation) b. Brugada syndrome (SCN5A-related sodium channelopathy) c. Short QT syndrome d. Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT; RyR2 or CASQ2 mutations) e. Long–Ganong–Levine syndrome f. Wolff–Parkinson–White syndrome or any form of pre-excitation due to an accessory pathway
- Third-degree Atrioventricular Block without a functioning pacemaker.
- Advanced His-Purkinje system disease or bifascicular block associated with syncope or presyncope without a functioning pacemaker.
- Prior history of sustained ventricular tachycardia without an AICD or Torsades de Pointes.
- Reversible causes of AF (e.g., hyperthyroidism, recent open- heart surgery, metabolic or electrolyte shift, or ongoing active ischemia).
- 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 and no antiarrhythmic concomitant drugs (or who wash out) and who are on stable DOAC for at least 3 weeks and who do not require a TEE to rule out thrombus.
- 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: a. Estimated glomerular filtration rate (eGFR) <30 mL/min at screening. b. Advanced hepatic disease. c. Advanced pulmonary disease. d. Severe psychiatric disorders, e.g., advanced dementia.
- Known allergy or hypersensitivity to amiodarone or iodine.
- Lactating Women: Breastfeeding women are excluded.
- Termination of previous amiodarone treatment for severe toxicity.
- Ongoing alcohol or substance abuse.
- Anemia [hemoglobin <10 g/deciliter (dL) at screening].
- Thrombocytopenia (platelet count <90,000/μL at screening).
- Active/uncontrolled thyroid disease, unexplained thyroid function test abnormalities under investigation, history of thyroid malignancy/nodules, or conditions/medications affecting thyroid function, unless stable for ≥3 months with normal thyroid function tests (stable hypo/hyperthyroid patients on consistent therapy are eligible).
- Any illness or condition judged by the investigator to compromise the participant’s safety during study drug administration.
- Concomitant Risks: Participants with conditions or treatments that could: a. Interfere with the study's conduct. b. Pose an unacceptable risk to safety, or compromise study data interpretation, such as: i. Life expectancy less than 2 years. ii. Active/suspected malignancy (except history of malignancy treated ≥2 years ago without evidence of recurrence). iii. Substance abuse (alcohol/illicit drugs) in the last 12 months. iv. Any known or suspicion for relevant infectious diseases associated with clinical signs (e.g., TSE/Cruetzfield Jacobs disease, Viral Hepatitis, HIV/AIDS, Ebola, West Nile virus, Zika virus). v. The participant is receiving analgesia via a continuous pain pump.
- Investigational Drug Use: Recent treatment with investigational drugs within 30 days or 5 half-lives, whichever is longer.
- Protocol Compliance: Subjects unable/unwilling to follow the study protocol.
- 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 (>500 ms with QRS ≤120 ms).
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.