Atrial FibrillationPhase 4RADICALNCT05004077
Repeated Amiodarone Dosing In Cardiac surgicaL Procedures
A Phase 4 study testing AMIODARONE in people with Atrial Fibrillation, run by Kevin W Hatton, MD, PhD at 1 site in United States.
Trial summary
This study is a single-center, prospective, randomized, open-label trial of subjects who develop atrial fibrillation after non-emergent cardiac surgery at the University of Kentucky Chandler Medical Center (UKCMC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- AMIODARONE
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2021to 10 Oct 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be 18 years old or older
- Subject must be willing to give written informed consent
- Subject must undergo or scheduled for non-emergent cardiac surgery, including coronary artery bypass grafting (CABG), non-infectious valve repair or replacement, atrial or septal defect repair, thoracic aortic replacement surgery, or any combination of these procedures
Who cannot join
- Documented allergy to amiodarone or iodine
- History of atrial fibrillation or other heart conduction system abnormality
- History of cardiac maze, pulmonary vein isolation, or other procedure affecting the conduction system
- Scheduled cardiac maze, pulmonary vein isolation, or other procedure affecting the conduction system
- Low cardiac index or cardiogenic shock requiring pharmacologic or mechanical support
- History of pre-existing respiratory system disease requiring oxygen therapy prior to admission
Show all 9Show fewer
- History of cirrhosis or other chronic liver diseases
- Pregnancy or breastfeeding mothers
- Prisoner status
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Medical Center
Lexington, Kentucky, 40536
About this study
This study is a single-center, prospective, randomized, open-label trial of subjects who develop atrial fibrillation after non-emergent cardiac surgery at the University of Kentucky Chandler Medical Center (UKCMC). Patients will be randomized to receive either a conventional amiodarone dosing regimen (CDR) or a repeated amiodarone bolus dosing regimen (RBDR).
Read the detailed description
This study will screen and consent approximately 150 patients undergoing non-emergent cardiac surgery. Approximately 60 of these patients are likely to develop stable postoperative atrial fibrillation (POAF) in the postoperative period. Amiodarone is commonly given as an initial intravenous (IV) bolus (150 mg IV) followed by a combined IV and oral load to a total dose of 8 gm. Because of amiodarone's beta-blocker activity, the IV bolus in patients with POAF is associated with a reduced heart rate that may lead to restoration of NSR. For this reason, some clinicians will provide up to 5 additional IV amiodarone boluses during the drug's loading period to treat RVR.
- Conditions
- Atrial Fibrillation
- Being tested
- AMIODARONE
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMIODARONEDrug
Assess the effectiveness of different dosing strategies of amiodarone.
| Study group | Role | What they receive |
|---|---|---|
| Conventional amiodarone dosing regimen (CDR) | Active comparator | Initial amiodarone bolus of 150 mg IV over 10 minutes then a 24-hour amiodarone loading infusion (1 mg/min for 6 hours followed by 0.5 mg/min for 18 hours), followed by enteral (400 mg amiodarone oral or per tube three times daily or 2 times daily if the patient has gastrointestinal intolerance when taking the drug three times daily) or intravenous amiodarone (0.5 mg/min continuous infusion) to complete an 8-gm total amiodarone load. Maintenance amiodarone (200 mg amiodarone oral or per tube once daily) at discretion of attending physician. Receives: Drug: AMIODARONE |
| Repeated amiodarone bolus dosing regimen (RBDR) | Active comparator | Initial amiodarone bolus of 150 mg IV over 10 minutes, then 1.0 mg/min IV amiodarone infusion for 6 hours, then a 0.5 mg/min IV amiodarone infusion for 18 hours, followed by enteral (400 mg amiodarone oral or per tube three times daily or 2 times daily if the patient has gastrointestinal intolerance when taking the drug three times daily) or intravenous amiodarone (0.5 mg/min continuous infusion) to complete an 8-gm total amiodarone load. In addition, patients in the RBDR will receive an additional 150 mg IV amiodarone bolus whenever the patient develops tachycardia (Heart Rate (HR) = 110 beats per minute) lasting more than 10 minutes. This bolus may be repeated up to a total of 5 times (6 total boluses) over the first 24 hours. Maintenance amiodarone (200 mg amiodarone oral or per tube once daily) at discretion of attending physician. Receives: Drug: AMIODARONE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal Sinus Rhythm -24 HRS
Percentage of patients who develop stable POAF after non-emergent cardiac surgery, the percentage of patients who have converted to NSR at 24-hours after receiving a repeated amiodarone bolus and loading dose regimen to the percentage of patients who have converted to NSR after a conventional amiodarone IV loading dose regimen.
Measured: 24-hours after receiving amiodarone bolus
Secondary outcomes (4)
Total Target Heart Rate Time
Total time, in minutes, during the first 24 hours that the patient achieves target HR (HR < 110 bpm) between patients who receive a repeated amiodarone bolus dosing regimen and those who receive a conventional amiodarone bolus dosing regimen
Measured: 24-hours after receiving amiodarone bolus
Time to Target Heart Rate
Time to achieve target HR (HR < 110 bpm) between patients who receive a repeated amiodarone bolus dosing regimen and those who receive a conventional amiodarone bolus dosing regimen
Measured: 24-hours after receiving amiodarone bolus
Normal Sinus Rhythm -Hospital Index
Percentage of patients who achieve NSR by ICU discharge and hospital discharge between patients who receive a repeated amiodarone bolus dosing regimen and those who receive a conventional amiodarone bolus dosing regimen
Measured: duration of ICU and hospital visit, up to 20 days
Recurrent AF
Percentage of patients who have recurrent AF before ICU discharge and before hospital discharge and patients who receive a repeated amiodarone bolus dosing regimen and those who receive a conventional amiodarone bolus dosing regimen
Measured: duration of ICU and hospital visit, up to 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start2 Nov 2021
- Primary completion10 Oct 2022
- Study completion10 Oct 2022
Why it stopped: limited enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kevin W Hatton, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kevin W Hatton, MD, PhD, University of Kentucky
- Investigators
- Kevin Hatton, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004077
- Sponsor's protocol ID
- 67919
- Acronym
- RADICAL
- Status last verified
- Oct 2023
- First submitted
- 2 Aug 2021
- Last updated
- 18 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Amiodarone Dosing In Cardiac surgicaL Procedures
- ClinicalTrials.gov ID
- NCT05004077
- Acronym / sponsor ID
- RADICAL / 67919
- Conditions
- Atrial Fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: limited enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Kevin W Hatton, MD, PhDUniversity, hospital or other
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 13 Aug 2021 (actual)
- Results
- Posted 18 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single-center, prospective, randomized, open-label trial of subjects who develop atrial fibrillation after non-emergent cardiac surgery at the University of Kentucky Chandler Medical Center (UKCMC). Patients will be randomized to receive either a conventional amiodarone dosing regimen (CDR) or a repeated amiodarone bolus dosing regimen (RBDR).
Detailed description
This study will screen and consent approximately 150 patients undergoing non-emergent cardiac surgery. Approximately 60 of these patients are likely to develop stable postoperative atrial fibrillation (POAF) in the postoperative period. Amiodarone is commonly given as an initial intravenous (IV) bolus (150 mg IV) followed by a combined IV and oral load to a total dose of 8 gm. Because of amiodarone's beta-blocker activity, the IV bolus in patients with POAF is associated with a reduced heart rate that may lead to restoration of NSR. For this reason, some clinicians will provide up to 5 additional IV amiodarone boluses during the drug's loading period to treat RVR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional amiodarone dosing regimen (CDR) | Active comparator | Drug: AMIODARONEInitial amiodarone bolus of 150 mg IV over 10 minutes then a 24-hour amiodarone loading infusion (1 mg/min for 6 hours followed by 0.5 mg/min for 18 hours), followed by enteral (400 mg amiodarone oral or per tube three times daily or 2 times daily if the patient has gastrointestinal intolerance when taking the drug three times daily) or intravenous amiodarone (0.5 mg/min continuous infusion) to complete an 8-gm total amiodarone load. Maintenance amiodarone (200 mg amiodarone oral or per tube once daily) at discretion of attending physician. |
| Repeated amiodarone bolus dosing regimen (RBDR) | Active comparator | Drug: AMIODARONEInitial amiodarone bolus of 150 mg IV over 10 minutes, then 1.0 mg/min IV amiodarone infusion for 6 hours, then a 0.5 mg/min IV amiodarone infusion for 18 hours, followed by enteral (400 mg amiodarone oral or per tube three times daily or 2 times daily if the patient has gastrointestinal intolerance when taking the drug three times daily) or intravenous amiodarone (0.5 mg/min continuous infusion) to complete an 8-gm total amiodarone load. In addition, patients in the RBDR will receive an additional 150 mg IV amiodarone bolus whenever the patient develops tachycardia (Heart Rate (HR) = 110 beats per minute) lasting more than 10 minutes. This bolus may be repeated up to a total of 5 times (6 total boluses) over the first 24 hours. Maintenance amiodarone (200 mg amiodarone oral or per tube once daily) at discretion of attending physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject must be 18 years old or older
- Subject must be willing to give written informed consent
- Subject must undergo or scheduled for non-emergent cardiac surgery, including coronary artery bypass grafting (CABG), non-infectious valve repair or replacement, atrial or septal defect repair, thoracic aortic replacement surgery, or any combination of these procedures
Key exclusion criteria (9 listed)
- Documented allergy to amiodarone or iodine
- History of atrial fibrillation or other heart conduction system abnormality
- History of cardiac maze, pulmonary vein isolation, or other procedure affecting the conduction system
- Scheduled cardiac maze, pulmonary vein isolation, or other procedure affecting the conduction system
- Low cardiac index or cardiogenic shock requiring pharmacologic or mechanical support
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMIODARONEAssess the effectiveness of different dosing strategies of amiodarone. | Drug | Conventional amiodarone dosing regimen (CDR), Repeated amiodarone bolus dosing regimen (RBDR) |
Primary outcome
Normal Sinus Rhythm -24 HRS
Time frame: 24-hours after receiving amiodarone bolus
Percentage of patients who develop stable POAF after non-emergent cardiac surgery, the percentage of patients who have converted to NSR at 24-hours after receiving a repeated amiodarone bolus and loading dose regimen to the percentage of patients who have converted to NSR after a conventional amiodarone IV loading dose regimen.
4 secondary outcomes
Total Target Heart Rate Time
Time frame: 24-hours after receiving amiodarone bolus
Time to Target Heart Rate
Time frame: 24-hours after receiving amiodarone bolus
Normal Sinus Rhythm -Hospital Index
Time frame: duration of ICU and hospital visit, up to 20 days
Recurrent AF
Time frame: duration of ICU and hospital visit, up to 20 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Hatton, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AMIODARONE in people with Atrial Fibrillation, run by Kevin W Hatton, MD, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normal Sinus Rhythm -24 HRS (time frame: 24-hours after receiving amiodarone bolus). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.