Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients Pilot Trial

Atrial Fibrillation New Onset Clinical Trial

— START-POAF  

Official title:

Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients (START-POAF) Pilot Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05841056
• Other study ID #: 2023.START-POAF
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 31, 2024
• Est. completion date: January 30, 2026

Study information

• Verified date: March 2024
• Source: Population Health Research Institute
• Contact: Ingrid Copland
• Phone: 905-512-4940
• Email: start-poaf[@]phri.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: January 30, 2026
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Aged =18 years;

2. Have undergone cardiac surgery including CABG, valve surgery, ascending aorta replacement, or combinations thereof within 14 days of randomization;

3. Had new-onset POAF (or flutter), documented by 12-lead ECG or lasting = 1 hour on telemetry. Patients can be in AF or sinus rhythm at the time of randomization;

4. Expected to receive 3 g - 5 g of amiodarone loading dose post-surgery.

5. Expected to be ready for hospital discharge within 48 h of randomization.

Exclusion Criteria:

1. Documented preoperative history of paroxysmal, persistent or permanent AF;

2. Planned use of a class I or III anti-arrhythmic drug (other than study drug);

3. Patients who have undergone heart transplant, complex congenital heart surgery, isolated ventricular assist device insertion, or AF ablation (surgical or catheter);

4. Known allergy to ECG adhesives;

5. Contraindication to amiodarone (i.e. hyperthyroidism, severe restrictive or obstructive lung disease, Long QT syndrome, PR > 240 ms, high-grade AV block).

6. Individuals who are pregnant, breastfeeding, or of childbearing potential - female subjects, premenopausal who are not surgically sterile, or, if sexually active not practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and, for those of childbearing potential, who have a positive pregnancy test at screening

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation New Onset

Intervention

Drug:
• Amiodarone Hydrochloride 200 MG
200 mg daily for 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Population Health Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart Failure	Number of participants who experience heart failure	90 days after randomization
Other	Atrial Fibrillation	Number of participants who experience atrial fibrillation	90 days after randomization
Other	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	90 days after randomization
Other	Major bleeding	Number of participants who experience a major bleed	90 days after randomization
Other	Systemic arterial embolism	Number of participants who experience a systemic arterial embolism	90 days after randomization
Other	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	Collected at baseline, 30 day follow-up and 90 day follow-up
Other	SF-12 Questionnaire	The SF-12 questionnaire which assesses physical and mental health will be completed on all participants	Collected at baseline, 30 day follow-up and 90 day follow-up
Other	Electrical cardioversion	Proportion of participants who undergo electrical cardioversion	Randomization to 90 days
Primary	3 patients per center per month	Ability to recruit an average of 3 participants per center per month	2 years
Primary	Less than 10% cross-over rate	Less than 10% cross-over rate	28 days
Primary	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	28 days
Primary	90% follow-up at 30 days	Greater than and equal to 90% follow-up at 30 days	At 30 days post randomization date
Secondary	Burden of atrial fibrillation	Defined as percent time in atrial fibrillation	In the 28 days measured by the continuous ECG monitor placed on the day after the participant finishes their 3-5g amiodarone loading dose
Secondary	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	In the 28 days measured by the continuous ECG monitor placed on the day after the participant finishes their 3-5g amiodarone loading dose
Secondary	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	In the 28 days measured by the continuous ECG monitor placed on the day after the participant finishes their 3-5g amiodarone loading dose