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Heart pill hopes dashed: atrial fibrillation study shut down after just 3 patients

NCT ID NCT04594746

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Show 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.

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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