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A study to evaluate the safety and effectiveness of budiodarone tartrate in patients with non-permanent atrial fibrillation

Recommended centreFast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals living with Non-permanent Atrial Fibrillation, a condition where the heart beats irregularly at times. The investigation aims to evaluate the safety and effectiveness of a medication called budiodarone. This drug is administered in the form of an oral capsule.

The research involves checking how well the medicine works to prevent LEAF, which refers to long, continuous episodes of irregular heart rhythms lasting five hours or more. During the study, participants will be monitored for adverse events, which are any unexpected or harmful medical occurrences that happen during treatment. This includes watching for major adverse cardiac events, such as a stroke or issues related to sudden heart rhythm changes. Regular checks of vital signs, like blood pressure and heart rate, as well as laboratory assessments to monitor organ functions like the thyroid, will be conducted throughout the process.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>Medication administration</b>

    The budiodarone tartrate capsule is taken by oral use.

    The dose is 1600 mg.

  2. Step 2

    <b>Safety and health monitoring</b>

    Physical exams and vital sign assessments are performed to monitor health.

    Clinical laboratory assessments are conducted, which include checking thyroid function.

    Monitoring is performed for adverse events, which are any unwanted medical occurrences during the study, including serious adverse events or major adverse cardiac events (significant heart-related issues).

  3. Step 3

    <b>Efficacy evaluation</b>

    The effectiveness of the treatment is measured by tracking LEAF episodes. LEAF refers to an uninterrupted episode of atrial fibrillation (an irregular heart rhythm) that lasts 5 hours or longer, or a total duration of irregular heart rhythm exceeding 5 hours within any 24-hour period.

    In the final month of treatment, the goal is to determine the proportion of time without these episodes.

    Additional measurements include changes in atrial fibrillation symptom score (AFSS) and atrial fibrillation burden (AFB) compared to the start of the study.

Who can join the trial?

15 criteria

  • You must be an adult between the ages of 18 and 80 years old.
  • You must have a diagnosis of paroxysmal atrial fibrillation, which is a type of irregular heartbeat that comes and goes, or be undergoing elective cardioversion, a medical procedure used to restore a normal heart rhythm.
  • If you have a pacemaker or an implantable loop recorder (a small device placed under the skin to monitor heart rhythm), your device must have recorded long episodes of irregular heartbeats lasting more than 5 hours within the 3 months before joining the study.
  • If you do not have a device, your irregular heartbeats must be tracked using wearable bands or patches.
  • During a 28-day period before starting the study, you must have had at least 5% of your heartbeats be irregular, along with specific patterns of long episodes lasting 5 hours or more.
  • You must have tried and failed at least one previous treatment for your irregular heartbeat, such as antiarrhythmic drugs (medicines used to control heart rhythm), rate control drugs (medicines used to slow down a fast heart rate), or catheter ablation (a procedure that uses energy to destroy small areas of heart tissue causing irregular rhythms).
  • Your AFSS score (a scale used to measure the burden or severity of irregular heartbeats) must be greater than 3.
  • You must have a specific CHA2DS2-VASc score (a tool used to estimate the risk of stroke) of 1 or more for men, or 2 or more for women.
  • You must have been taking an oral anticoagulant (a blood-thinning medication used to prevent blood clots) for at least 3 weeks before starting the study medication.
  • You must have NYHA Class I or II heart failure, which describes mild to moderate symptoms of the heart not pumping blood as well as it should.
  • If you have NYHA Class II heart failure or a documented ejection fraction (a measurement of how much blood the heart pumps out with each beat) below 45% in the last two years, you will need to complete extra medical checks.
  • You must be able to understand the study requirements, follow all instructions, attend all visits, and complete all planned tests.
  • You must be able and willing to provide informed consent, which is a written agreement showing you understand the study and agree to participate.
  • Women must have gone through menopause for at least one year or be surgically sterile; if not, you must agree to use an approved method of contraception (birth control) to prevent pregnancy.
  • Men must agree to use an approved method of contraception throughout the 12-week treatment period.

Who cannot join the trial?

28 criteria

  • Women who are pregnant, planning to become pregnant, or not using effective contraception (methods like birth control pills or barrier methods to prevent pregnancy).
  • People with a history of congenital or primary cardiac channelopathies, which are inherited electrical problems in the heart that control its rhythm.
  • Specific electrical heart conditions including Long QT Syndrome, Brugada syndrome, Short QT syndrome, Catecholaminergic Polymorphic Ventricular Tachycardia, Long–Ganong–Levine syndrome, or Wolff–Parkinson–White syndrome.
  • People with third-degree atrioventricular block, a serious heart rhythm problem where the electrical signal cannot pass from the upper to the lower chambers, unless they have a working pacemaker (a small device implanted to control the heartbeat).
  • People with advanced His-Purkinje system disease or bifascicular block (problems with the heart's electrical conduction system) that cause syncope (fainting) or presyncope (feeling like one might faint), unless they have a working pacemaker.
  • A history of sustained ventricular tachycardia (a fast heart rate starting in the lower chambers) without an AICD (an implanted device that can shock the heart back to a normal rhythm) or Torsades de Pointes (a specific type of dangerous heart rhythm).
  • Having reversible causes of AF (atrial fibrillation, which is an irregular heart rhythm), such as hyperthyroidism (an overactive thyroid), recent heart surgery, changes in body chemistry, or ischemia (insufficient blood flow to the heart).
  • People with persistent AF, meaning the irregular heart rhythm lasts for 7 days or more, unless they meet very specific medical requirements.
  • Recent use of certain rhythm control medications (medicines used to fix heart rhythms) or amiodarone (a specific heart medication) within certain timeframes.
  • Having a cardiac ablation (a procedure to destroy small areas of heart tissue to fix rhythm problems) within the last 30 days or having one scheduled soon.
  • Severe end-organ disease, which includes kidney disease (measured by a low eGFR, which shows how well kidneys filter blood), advanced liver disease, advanced lung disease, or severe mental health conditions like dementia.
  • A known allergy or hypersensitivity to amiodarone or iodine.
  • Women who are lactating (breastfeeding).
  • People who had to stop taking amiodarone previously because it was too toxic to their body.
  • Ongoing use of alcohol or substance abuse.
  • Anemia, which means having a low level of hemoglobin (the protein in red blood cells that carries oxygen).
  • Thrombocytopenia, which is a low platelet count (platelets are the cells that help blood clot).
  • Active or uncontrolled thyroid disease, unless it has been stable for at least 3 months.
  • Any other illness that the doctor believes makes participating in the study unsafe.
  • Conditions that could make the study results unreliable, such as a life expectancy of less than 2 years or active malignancy (cancer).
  • Suspected infectious diseases such as Viral Hepatitis, HIV/AIDS, or other viruses.
  • People using a continuous pain pump (a device that delivers pain medicine constantly).
  • Recent use of other investigational drugs (medicines being tested in research).
  • An inability or unwillingness to follow the rules of the study.
  • NYHA Class 3 or 4 heart failure, which refers to severe symptoms and limitations in daily activities due to heart failure.
  • A recent MI (heart attack), ischemic stroke (stroke caused by lack of blood to the brain), or venous thromboembolism (blood clots in the veins) within the last 3 months.
  • Recent unstable angina (chest pain that is unpredictable), PTCA (a procedure to open blocked heart arteries), or CABG (heart bypass surgery) within the last 3 months.
  • A prolonged QTcF interval, which is a measurement showing that the heart's electrical system takes too long to recharge between beats.
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Investigated drugs

Budiodarone is an oral medication taken in capsule form that is being studied to see if it can help treat people with a type of irregular heartbeat known as non-permanent atrial fibrillation.

What is already known about the treatment

Budiodarone tartrate - This medication is taken by mouth in the form of a capsule and is currently being studied in clinical trials to evaluate its safety and effectiveness. It belongs to a class of drugs known as antiarrhythmics and is used to help control irregular heart rhythms, specifically non-permanent atrial fibrillation. At a molecular level, it works by blocking certain electrical signals in the heart cells to help maintain a steady and normal heartbeat.

Investigated diseases

Paroxysmal Atrial Fibrillation - This is a type of irregular heartbeat where the upper chambers of the heart beat out of sync with the lower chambers. It is characterized by episodes of rapid and irregular heart rhythms that start and end suddenly. These episodes can last for a few minutes or several hours. The heart rhythm typically returns to a normal pattern on its own after the episode ends. Over time, the frequency or duration of these episodes may change.
Trial detailsLast updated 31 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-523860-19-00Protocol codeCLN-209Estimated enrolment600 patientsSponsorXyra LLC

sourced from the EU Clinical Trials Register and site verification

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