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

Primary Purpose

Atrial Fibrillation New Onset

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Amiodarone Hydrochloride 200 MG
Sponsored by
Population Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation New Onset focused on measuring cardiac surgery, heart rhythm monitoring, amiodarone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged ≥18 years; Have undergone cardiac surgery including CABG, valve surgery, ascending aorta replacement, 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. Patients can be in AF or sinus rhythm at the time of randomization; 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. Exclusion Criteria: 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 (surgical or catheter); Known allergy to ECG adhesives; Contraindication to amiodarone (i.e. hyperthyroidism, severe restrictive or obstructive lung disease, Long QT syndrome, PR > 240 ms, high-grade AV block). 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Amiodarone maintenance therapy

    No Amiodarone maintenance therapy

    Arm Description

    Amiodarone 200 mg daily for four weeks

    No ongoing Amiodarone maintenance therapy for four weeks

    Outcomes

    Primary Outcome Measures

    3 patients per center per month
    Ability to recruit an average of 3 participants per center per month
    Less than 10% cross-over rate
    Less than 10% cross-over rate
    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
    90% follow-up at 30 days
    Greater than and equal to 90% follow-up at 30 days

    Secondary Outcome Measures

    Burden of atrial fibrillation
    Defined as percent time in atrial fibrillation
    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
    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

    Full Information

    First Posted
    April 4, 2023
    Last Updated
    August 18, 2023
    Sponsor
    Population Health Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05841056
    Brief Title
    Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients Pilot Trial
    Acronym
    START-POAF
    Official Title
    Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients (START-POAF) Pilot Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 7, 2023 (Anticipated)
    Primary Completion Date
    September 30, 2025 (Anticipated)
    Study Completion Date
    December 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Population Health Research Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation New Onset
    Keywords
    cardiac surgery, heart rhythm monitoring, amiodarone

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    1:1 ratio to receive amiodarone 200 mg maintenance therapy daily for four weeks or no maintenance therapy
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Amiodarone maintenance therapy
    Arm Type
    Active Comparator
    Arm Description
    Amiodarone 200 mg daily for four weeks
    Arm Title
    No Amiodarone maintenance therapy
    Arm Type
    No Intervention
    Arm Description
    No ongoing Amiodarone maintenance therapy for four weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Amiodarone Hydrochloride 200 MG
    Other Intervention Name(s)
    Pacerone, Cordarone
    Intervention Description
    200 mg daily for 4 weeks
    Primary Outcome Measure Information:
    Title
    3 patients per center per month
    Description
    Ability to recruit an average of 3 participants per center per month
    Time Frame
    2 years
    Title
    Less than 10% cross-over rate
    Description
    Less than 10% cross-over rate
    Time Frame
    28 days
    Title
    Intervention group taking at least 80% of their amiodarone 4 week maintenance therapy
    Description
    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
    Title
    90% follow-up at 30 days
    Description
    Greater than and equal to 90% follow-up at 30 days
    Time Frame
    At 30 days post randomization date
    Secondary Outcome Measure Information:
    Title
    Burden of atrial fibrillation
    Description
    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
    Title
    Time to first AF > 6 minutes, >6 hours and >24 hours
    Description
    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
    Title
    Participants with at least one episode >6 minutes, >6 hours and >24 hours
    Description
    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
    Other Pre-specified Outcome Measures:
    Title
    Heart Failure
    Description
    Number of participants who experience heart failure
    Time Frame
    90 days after randomization
    Title
    Atrial Fibrillation
    Description
    Number of participants who experience atrial fibrillation
    Time Frame
    90 days after randomization
    Title
    A composite of stroke, myocardial infarction and cardiovascular death
    Description
    Number of participants who have at least one of the following: stroke, myocardial infarction or cardiovascular death
    Time Frame
    90 days after randomization
    Title
    Major bleeding
    Description
    Number of participants who experience a major bleed
    Time Frame
    90 days after randomization
    Title
    Systemic arterial embolism
    Description
    Number of participants who experience a systemic arterial embolism
    Time Frame
    90 days after randomization
    Title
    Atrial Fibrillation Effect on QualiTy of life (AFEQT) Questionnaire
    Description
    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
    Title
    SF-12 Questionnaire
    Description
    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
    Title
    Electrical cardioversion
    Description
    Proportion of participants who undergo electrical cardioversion
    Time Frame
    Randomization to 90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged ≥18 years; Have undergone cardiac surgery including CABG, valve surgery, ascending aorta replacement, 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. Patients can be in AF or sinus rhythm at the time of randomization; 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. Exclusion Criteria: 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 (surgical or catheter); Known allergy to ECG adhesives; Contraindication to amiodarone (i.e. hyperthyroidism, severe restrictive or obstructive lung disease, Long QT syndrome, PR > 240 ms, high-grade AV block). 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ingrid Copland
    Phone
    905-512-4940
    Email
    start-poaf@phri.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    William McIntyre, MD
    Organizational Affiliation
    Population Health Research Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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