A Phase 3 interventional study of Amiodarone Hydrochloride 200 MG in Atrial Fibrillation New Onset, sponsored by Population Health Research Institute. Recruiting at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Population Health Research Institute · Phase 3, Interventional, and Treatment
The START-POAF pilot study is a prospective, open-label two-arm, randomized controlled trial with blinded assessment of outcomes (PROBE). This pilot study will assess Atrial Fibrillation (AF) recurrence and burden in patients with new-onset AF following cardiac surgery.
Atrial fibrillation (AF) is the most common abnormal heart rhythm in the world. In patients who have cardiac surgery, new AF is found as an early complication in more than one out of every four surgeries. In the weeks and months after heart surgery, patients who have new AF take a medication called amiodarone to keep their heart in rhythm as it heals. If the heart goes back into AF, patients can have symptoms of heart racing, heart failure (fluid on the lungs) or stroke. Although amiodarone is effective, it can have side effects like dizziness, nausea and slow heart rate. It may also damage the lungs, liver and thyroid gland. Many patients are not able to complete their full prescribed course after surgery. Therefore, it is crucial that the investigators find the shortest possible length of treatment with amiodarone that will keep the heart in rhythm while minimizing the chance of side effects or organ damage. The START-POAF Pilot Randomized Trial will compare two different durations of amiodarone treatment: 1) in-hospital load only and 2) in-hospital load plus 4 weeks after loading dose. All participants will wear an electrocardiogram (ECG) monitor for 4 weeks the day after they complete their loading dose. The investigators will compare the amount of AF seen on the ECG between the two groups.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 400 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Population Health Research Institute is the lead sponsor of 115 studies on the registry; 26 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Amiodarone 200 mg daily for four weeks
Drug: Amiodarone Hydrochloride 200 MG
No ongoing Amiodarone maintenance therapy for four weeks
200 mg daily for 4 weeks
Also known as: Pacerone, Cordarone
3 patients per center per month
Ability to recruit an average of 3 participants per center per month
Time frame: 2 years
Less than 10% cross-over rate
Less than 10% cross-over rate
Time frame: 28 days
Intervention group taking at least 80% of their amiodarone 4 week maintenance therapy
Greater than and equal to 90% of the intervention group taking at least 80% of their amiodarone 4 week maintenance therapy
Time frame: 28 days
90% follow-up at 30 days
Greater than and equal to 90% follow-up at 30 days
Time frame: At 30 days post randomization date
Recurrence of atrial fibrillation
AF recurrence lasting \>= 30 seconds within 28 days
Time frame: In the 28 days measured by continuous ECG monitor placed on day after the participant finishes their 3-5g of loading dose
Burden of atrial fibrillation
Defined as percent time in atrial fibrillation
Time frame: In the 28 days measured by the continuous ECG monitor placed on the day after the participant finishes their 3-5g amiodarone loading dose
Time to first AF > 6 minutes, >6 hours and >24 hours
Time to first AF \> 6 minutes, \>6 hours and \>24 hours reported from the continuous ECG monitor
Time frame: In the 28 days measured by the continuous ECG monitor placed on the day after the participant finishes their 3-5g amiodarone loading dose
Participants with at least one episode >6 minutes, >6 hours and >24 hours
Proportion of participants with at least one episode \> 6 minutes, \>6 hours and \>24 hours reported from the continuous ECG
Time frame: In the 28 days measured by the continuous ECG monitor placed on the day after the participant finishes their 3-5g amiodarone loading dose
Heart Failure
Number of participants who experience heart failure
Time frame: 90 days after randomization
Atrial Fibrillation
Number of participants who experience atrial fibrillation
Time frame: 90 days after randomization
A composite of stroke, myocardial infarction and cardiovascular death
Number of participants who have at least one of the following: stroke, myocardial infarction or cardiovascular death
Time frame: 90 days after randomization
Major bleeding
Number of participants who experience a major bleed
Time frame: 90 days after randomization
Systemic arterial embolism
Number of participants who experience a systemic arterial embolism
Time frame: 90 days after randomization
Atrial Fibrillation Effect on QualiTy of life (AFEQT) Questionnaire
The Atrial Fibrillation Effect on Quality-of-life Questionnaire (AFEQT) evaluates symptoms, daily activities, and treatment concerns participants have related to atrial fibrillation and will be completed on all participants
Time frame: Collected at baseline, 30 day follow-up and 90 day follow-up
SF-12 Questionnaire
The SF-12 questionnaire which assesses physical and mental health will be completed on all participants
Time frame: Collected at baseline, 30 day follow-up and 90 day follow-up
Electrical cardioversion
Proportion of participants who undergo electrical cardioversion
Time frame: Randomization to 90 days
Electrical cardioversion
Proportion of participants who undergo electrical cardioversion
Time frame: Randomization to 30 days
Plan to share: No
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Studies of the drug tested here: Amiodarone
Population Health Research Institute →