Hospitals interested in participating should be research ready and have established systems for obtaining IRB approval.
Once enrolled, hospitals will receive financial and programmatic support. This will include comprehensive training on: study protocols, patient enrollment, the AFib registry tool, and other study-related items. A team of experts will be available throughout the duration of the study to support hospitals with their CHANGE AFib work.
The trainings and resources will help support hospitals in enrolling eligible patients. The study aims to enroll 3,000 patients randomly assigned to study intervention, dronedarone and usual care vs. usual care alone. If hospitals have question, or need assistance, the CHANGE AFib team is ready to help.
Dive deeper into hospital participation and patient eligibility requirements.
What are the requirements for a hospital to participate in the trial?
- Hospitals must participate in the American Heart Association’s Get With The Guidelines® – AFib (GWTG-AFib) Registry
- Hospitals must be research-ready (e.g., have processes and systems for obtaining IRB approval)
- If your hospital is not part of GWTG-AFib and would like to learn more about joining, email firstname.lastname@example.org.
How many hospitals and patients can be a part of the trial?
The trial is targeting 200 U.S. based hospitals to enroll 3,000 patients.
How are data collected for the trial?
Data are collected in the American Heart Association’s Get With The Guidelines® – AFib (GWTG-AFib) Registry.
Will hospitals participating in the trial receive help and support for the duration of the trial?
Yes, a Program Director and Trial Program Manager will actively support all participating hospitals and will be available to address any trial-related questions. Once a site is signed up for the trial, the site can expect in depth training on trial protocols, patient selection, and data entry as well as ongoing support throughout the trial.
My hospital already participates in GWTG-AFib and submits data to the registry; will we have to collect and abstract additional data to participate in the trial?
There will be a minimal amount of additional data collection for the hospitalization episode. You will also collect data at two follow-up points:
- A mid-way time point, approximately 6 months post discharge
- An end-of-study time point at 12 months post discharge
How can a site sign up for CHANGE AFib and how does contracting work?
Sites will complete a Unified Participation Agreement (UPA), the official contract between the American Heart Association and the Participating Site, that allows the site to enroll and have access to AHA’s Get With The Guidelines on the registry platform. Sites already participating in GWTG-AFib with a UPA in place do not need to sign the UPA. Sites enrolled in a GWTG module other than AFib will sign an amendment to their existing UPA.
All sites will need to also sign the individual Participating Site Agreement which complements the UPA and outlines what the Participating Site is responsible for during the CHANGE AFib trial. The Site Agreement details what the CHANGE AFib trial will cover and formally outlines each parties understanding and responsibilities for conducting the trial. A Participating Site is required to sign both the UPA and the Site Agreement in order to participate in the CHANGE AFib trial.
Is IRB oversight necessary?
Does my site need to establish our own IRB?
Some sites participating in CHANGE-AFib may already have their own IRBs to oversee research conducted within the institution or by staff of the institution. Your site may use your own IRB to participate.
For those sites without an IRB, FDA regulations permit an institution without an IRB to arrange for an “outside” IRB to be responsible for initial and continuing review of studies conducted at a non-IRB institution. A central IRB has been established for CHANGE-AFib; AHA and DCRI staff can help a site navigate the process.
Patient Enrollment and Follow Up
What are the patient eligibility inclusion and exclusion criteria?
Participants are eligible to be included in the trial if ALL the following apply:
- Age 21 years or older
- First-detected AFib (defined as AFib diagnosed in the previous 120 days)
- Acute care encounter for evaluation or treatment of atrial fibrillation, within 120 days
- Electrocardiographic documentation of atrial fibrillation
- Estimated life expectancy of at least 1 year
- Patient or legal authorized representative capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) of the trial protocol
Participants are excluded from the trial if ANY of the following criteria apply:
- Patients with prior or planned treatment with rhythm control, either catheter ablation or chronic (>7 days) antiarrhythmic drug therapy
- Prior hospitalization for AFib (other than the qualifying event)
- Planned cardiothoracic surgery
- New York Heart Association class III or IV heart failure or a hospitalization for heart failure in the last 4 weeks
- Reduced ejection fraction (LVEF ≤40%)
- Permanent atrial fibrillation
- Ineligible for oral anticoagulation, unless CHA2DS2-VASc is less than 3, in women, or 2, in men.
- Bradycardia with a resting heart rate < 50 bpm
- PR interval >280 msec or 2nd degree or 3rd degree atrioventricular block without a permanent pacemaker/cardiac implanted electronic device
- Corrected QT interval ³500 msec
- Pregnancy or breast feeding
- Severe hepatic impairment in the opinion of the investigator
Why are patients being enrolled early with the condition?
There are no randomized clinical trials that address first-detected AFib treatment. Patients are often started on an atrioventricular nodal blocking agent (beta-blocker or non-dihydropyridine calcium channel blocker). The trial is investigating if earlier administration of a well-tolerated antiarrhythmic drug, shown to reduce hospitalization, may result in improved cardiovascular outcomes and quality of life in patients.
How long is the enrollment period?
Patients may be enrolled through Summer 2023.
Can we enroll patients on an outpatient basis?
YES. Get With The Guidelines – Atrial Fibrillation is an in-patient registry, however, outpatient enrollment is not prohibited. If you encounter a person who meets the inclusion and exclusion criteria and has recently been diagnosed with atrial fibrillation in the past 120 days, then they can be enrolled and randomized from clinic or the outpatient setting. If this occurs, there are several important things to keep in mind.
- As stated in the protocol, subjects must have a new diagnosis of atrial fibrillation within 120 days of randomization.
- If a participant is randomized to the intervention (dronedarone) arm they must be contacted within 10 days of the randomization to confirm the fulfillment and dosing start of their dronedarone prescription.
- Their baseline case report form needs to be filled out completely with information from their qualifying acute care encounter.
- The redcap database will need to be completed to allow randomization and treatment assignment.
Does a patient have to be admitted to the hospital to be eligible for CHANGE AFib?
In order to be eligible for CHANGE AFIB, a patient must have had an acute care encounter at the hospital for atrial fibrillation. For eligibility, this is defined as an acute care encounter and discharge from the emergency room, observation unit, or an inpatient admission.
At what point is a Cardioversion allowed after randomization in both the treatment and Usual Care arms?
A cardioversion is allowed at any time during the conduct of the trial (in either arm).
What follow-up is required of enrolled patients?
There are two pre-specified follow-up encounters.
- The first occurs approximately 6 months after randomization (with an eligibility window between 3 and 9 months). This encounter can be either in-person or through virtual assessment. At the 6-month visit, the 6-month follow-up form is completed in the GWTG-AFib registry.
- The second is the final follow-up encounter and occurs 12-months post randomization. Similar to the 6-month encounter, the final visit can be conducted either in-person or through virtual assessment. At the 12-month encounter, the 12-month follow-up form is completed in the GWTG-AFib registry. Patients who withdraw early or experience mortality will also have the final follow-up form completed.