Heart pill hopes dashed: atrial fibrillation study shut down after just 3 patients
NCT ID NCT04594746
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a single high dose (2000 mg) of the heart medication amiodarone, taken by mouth, could safely and quickly restore normal heart rhythm in people with acute atrial fibrillation. The trial planned to include both hospital and outpatient settings, but was terminated early after enrolling only 3 participants. Because it stopped so early, we cannot learn much from it about how well the treatment works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Amiodarone hydrochloride (a heart rhythm medication)
- What this could lead to
- If it had succeeded, this could have pointed toward a simple, single-dose pill to quickly restore normal heart rhythm in atrial fibrillation patients.
- What could go wrong
- The trial was terminated early with only 3 participants, so no reliable conclusions can be drawn. High-dose amiodarone also carries risks like lung or thyroid problems.
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
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
3 people
The number who actually took part.
- Started
-
Feb 2022
- Finished
-
Jan 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Acute persistent or paroxysmal atrial fibrillation or atrial flutter with duration \< 14 days (continuous with no spontaneous conversions), confirmed by ECG or cardiac telemetry * History of symptoms associated with atrial fibrillation * Appropriate anticoagulation (warfarin with an international normalized ratio (INR) \> 2.0 or direct oral anticoagulant) Exclusion Criteria: * Received \> 10 g of amiodarone in the prior 6 months, or other Class III anti-arrhythmic agents in the prior 3 months * previous severe adverse event following a cardioversion for atrial fibrillation * Hypothyroid and not on thyroid replacement therapy * Recent myocardial infarction (within 2 weeks) * Acute pulmonary oedema requiring hospital admission or New York Heart Association (NYHA) class IV heart failure * Severe left ventricular dysfunction or left ventricular ejection fraction \< 36%, as determined by cardiac imaging * Sick sinus syndrome, high grade atrioventricular block, ventricular rate \< 50 beats per minute in the absence of a mechanical pacemaker * Severe renal or hepatic disease * Known congenital long QT syndrome * Hypotension with systolic blood pressure \< 90 mmHg * Pregnant or breast-feeding women
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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.
Contacts and locations
Locations
-
University of Calgary
Calgary, Alberta, T2N 4Z6, Canada
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Other studies related to the condition(s) this trial covers.
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