Atrial Fibrillation New Onset study: Amiodarone Hydrochloride
Official title Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients Pilot Trial
ClinicalTrials.gov ID: NCT05841056
What this study is testing
What is Amiodarone Hydrochloride 200 MG?
This is an investigational medication being studied to see if a shorter course helps prevent new heart rhythm problems after heart surgery. It is designed to help keep the heart beating in a normal rhythm.
Also referred to as Pacerone, Cordarone.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to see if treating new heart rhythm problems right after surgery reduces how often they come back or how long they last.
- Who it's for
- People who have just had heart surgery and are experiencing a new, irregular heart rhythm called atrial fibrillation.
- What's involved
- Participants will be randomly assigned to receive either a short course of heart rhythm medicine or standard care, with their heart rhythms monitored closely.
- Time commitment
- The study involves short-term treatment and follow-up monitoring to track heart rhythm changes after surgery.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Aged ≥18 years;
- Have undergone cardiac surgery including CABG, valve surgery, surgery on the aorta, or combinations thereof within 14 days of randomization;
- Had new-onset POAF (or flutter), documented by 12-lead ECG or lasting ≥ 1 hour on telemetry.
- Expected to receive 3 g - 5 g of amiodarone loading dose post-surgery.
- Expected to be ready for hospital discharge within 48 h of randomization.
You likely can't join if
- Documented preoperative history of paroxysmal, persistent or permanent AF;
- Planned use of a class I or III anti-arrhythmic drug (other than study drug);
- Patients who have undergone heart transplant, complex congenital heart surgery, isolated ventricular assist device insertion, or AF ablation...
- Known allergy to ECG adhesives;
- Contraindication to amiodarone (i.e. hyperthyroidism, severe restrictive (Total Lung Capacity (TLC) \ 240 ms, high-grade AV block).
- Individuals who are pregnant, breastfeeding, or of childbearing potential - female people, premenopausal who are not surgically sterile, or, if...
The study team makes the final eligibility decision.
Where it is enrolling
- Hamilton, Ontario, Canada
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Hamilton, Ontario, Canada; Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.