Clinical trial NCT05130268: Early Dronedarone Versus Usual Care to Improve Outcomes in Persons With Newly Diagnosed Atrial Fibrillation
Official title: Pragmatic Randomized Clinical Trial of Early Dronedarone Versus Usual Care to Change and Improve Outcomes in Persons With First-Detected Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: Arrhythmias, Cardiac
Atrial Fibrillation
Anti-Arrhythmic Agents
Heterocyclic Compounds
Dronedarone
Multaq
Lead sponsor: American Heart Association
Sponsor class: OTHER
Collaborators: name: Duke Clinical Research Institute
name: Sanofi
First posted: 2021-11-23
Enrollment: 339
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, prospective, randomized, open-label, pragmatic clinical trial
Primary purpose: TREATMENT

Brief summary: While there are several completed clinical trials that address treatment strategy in patients with symptomatic and recurrent AF, there are no randomized clinical trials that address treatment for first-detected AF. In usual care, these patients are started on an atrioventricular nodal blocking agent (beta-blocker or non-dihydropyridine calcium channel blocker) along with stroke prevention therapy. The investigators hypothesize that earlier administration of a well-tolerated antiarrhythmic drug proven to reduce hospitalization may result in improved cardiovascular outcomes and quality of life in patients first-detected AF.

The purpose of this study is to determine if treatment with dronedarone on top of usual care is superior to usual care alone for the prevention of cardiovascular hospitalization or death from any cause in patients hospitalized with first-detected AF. All patients will be treated with guideline-recommended stroke prevention therapy according to the CHA2DS2-VASc score. The treatment follow-up period will be 12 months. There will be two follow-up visits. Consistent with the pragmatic nature of the trial, the first follow-up will occur between 3 -9 months and the 2nd will occur at 12 months (with a window of +/- 30 days). Approximately 3000 patients will be enrolled and randomly assigned (1:1) to study intervention. The study intervention will be dronedarone 400 mg twice daily in addition to usual care versus usual care alone.

Detailed description: Atrial fibrillation (AF) is the most common sustained arrhythmia encountered in clinical practice, accounting for one-third of arrhythmia-related hospitalizations.1 As many as 1 in 4 people develop AF over their lifetime after the age of 40 years. The prevalence and burden of AF in the United States is substantial; the age-adjusted incidence and prevalence has increased over the last 3 decades. Moreover, the number of Americans with AF is expected to increase 150% by 2050. The goals of care in the treatment of AF include (1) the management and reduction of risk factors, (2) prevention of tachycardia (rate control), (3) prevention of stroke, and (4) improvement of symptoms. Reduction or elimination of symptoms often requires rhythm control. Historically, randomized clinical trials have not demonstrated a mortality or stroke benefit with a rhythm control versus a rate control strategy.

Despite the failure of prior randomized clinical trials to demonstrate the superiority of rhythm control, the recent Early Treatment of Atrial Fibrillation for Stroke Prevention 4 (EAST-AFNET 4) trial demonstrated that early introduction of a comprehensive rhythm-control strategy (within one year of diagnosis) is superior to guideline-based usual care in improving cardiovascular (CV) outcomes at a mean follow-up of 5 years. The EAST-AFNET 4 trial found that early rhythm control reduced the primary outcome of CV death, stroke, hospitalization for heart failure (HF), or acute coronary syndrome (HR 0.79, 96% confidence interval (CI) 0.66-0.94, p = 0.005). EAST-AFNET 4 also demonstrated a reduction in the risk of stroke with early introduction of rhythm control (HR 0.65, 95% CI 0.44-0.98), a finding that was also observed with dronedarone in the ATHENA trial. In addition, maintenance of sinus rhythm has been associated with improved quality of life and increased exercise capacity in some patients. Outside of clinical trials, a quality-of-life study from the Registry on Cardiac Rhythm Disorders Assessing the Control of Atrial Fibrillation (RECORD-AF) found that rhythm control was associated with better quality of life.

There are several antiarrhythmic drugs (AADs) available for rhythm control of AF. Class I antiarrhythmic agents are predominantly limited to younger patients without coronary artery or structural heart disease. Patients with advanced chronic kidney disease, prolonged QT intervals, and/or severe left ventricular hypertrophy should not be treated with sotalol or dofetilide. Even when sotalol or dofetilide can be used, patients are often hesitant to start a medication that requires an inpatient hospitalization for drug loading and laboratory evaluation every 3 months. Amiodarone has been shown to be the most effective AAD for maintaining sinus rhythm in patients with AF; however, based on its side effect profile, amiodarone is only recommended as a first-line agent under specific clinical circumstances. Moreover, despite its efficacy, amiodarone has high rates of discontinuation due to frequent adverse events. In addition to its unfavorable side effects, several studies, including those of patients at risk for sudden cardiac death, have demonstrated an association between amiodarone use and higher mortality, as well as lower functional status. In contrast to amiodarone, dronedarone is a much better tolerated antiarrhythmic medication. In randomized controlled trials, dronedarone has been shown to prevent recurrent AF, improve rate control, and decrease cardiovascular hospitalization in patients with AF.

While there are several completed clinical trials that address treatment strategy in patients with symptomatic and recurrent AF, there are no randomized clinical trials that address treatment for first-detected or new-onset AF. After appropriate evaluation for oral anticoagulation, these patients are often started on an atrioventricular nodal blocking agent (beta-blocker or non-dihydropyridine calcium channel blocker). The investigators hypothesize that earlier administration of a well-tolerated antiarrhythmic drug proven to reduce hospitalization may result in improved quality of life and cardiovascular outcomes in patients with first-detected AF.

Risk Assessment:

Dronedarone is approved by the Food and Drug Administration to reduce the risk of hospitalization for AF in patients with paroxysmal or persistent AF. The efficacy and safety of dronedarone 400 mg twice daily was evaluated in five controlled studies, ATHENA, ANDROMEDA, European Trial in Atrial Fibrillation or Flutter Patients Receiving Dronedarone for the Maintenance of Sinus Rhythm (EURIDIS), ADONIS, and Dronedarone Atrial FibrillatioN study after Electrical Cardioversion (DAFNE), involving more than 6,000 patients with including more than 3200 patients who received dronedarone. As with any therapeutic agent, there are known risks with dronedarone therapy. These risks include hepatic injury, heart failure exacerbation, increased exposure to digoxin, increased plasma concentration of tacrolimus, sirolimus, and other Cytochrome P450, family 3, subfamily A (CYP 3A) substrates, and very rare instances of pulmonary toxicity. The risks of dronedarone are felt to be outweighed by its benefits. The guideline recommendations provided by the European Society of Cardiology and American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Rhythm Society (HRS) are commensurate with this risk benefit assessment.

Benefit Assessment:

While there are no completed randomized clinical trials to guide selection or initiation of rhythm control therapies in patients with first-detected AF, there are recent trials that suggest benefit with both dronedarone antiarrhythmic therapy and early-initiation of rhythm control in persons with AF. the recent EAST-AFNET 4 trial demonstrated that early introduction of a comprehensive rhythm-control strategy (within one year of diagnosis) is superior to usual guideline-recommended care in improving cardiovascular (CV) outcomes at 5 years. The median time from new-onset AF to randomization in the EAST-AFNET4 trial was 36 days. The trial found that early rhythm control reduced the primary outcome of CV death, stroke, hospitalization for HF, or acute coronary syndrome (HR 0.79, 95% confidence interval 0.66-0.94, p = 0.005). EAST-AFNET 4 also demonstrated a reduction in the risk of stroke with early introduction of rhythm control (HR 0.65, 95% CI 0.44-0.98), a finding that was also observed with dronedarone in the ATHENA trial. Thus, the investigators hypothesize that early initiation of dronedarone in patients with new-onset AF will lead to a reduction in CV hospitalization or death.

Overall Design:

Dronedarone is approved by the Food and Drug Administration to reduce the risk of CV hospitalization in patients with AF or atrial flutter. However, it is unknown if dronedarone (or any antiarrhythmic medication) can reduce CV hospitalization or death in patients with first-detected AF. This trial has been designed to address this important question. In order to facilitate the trial enrollment, data collection, and a generalizability to clinical practice, the CHANGE AFIB study has been designed as an open-label pragmatic clinical trial nested within the Get With The Guidelines (GWTG) Atrial Fibrillation registry. At present the overall GWTG program is being implemented in over 2,300 hospitals across the U.S. and is comprised of over 9 million patient records, with an estimated 650,000 new patient records entered per year. The trial will utilize the existing GWTG registry network, data collection architecture, and experience to facilitate both enrollment and conduct of the trial.

The comparator arm will be "usual care." Thus, this study will compare usual care plus dronedarone versus usual care alone. In most patients, the investigators anticipate usual care to include an atrioventricular nodal blocking agent (beta-blocker, non-dihydropyridine calcium channel blocker, or digoxin) without an antiarrhythmic. As dronedarone has anti-adrenergic rate controlling properties, a low dose of beta-blocker or calcium-channel blocker is recommended in the USPI when starting dronedarone. In the dronedarone arm concomitant digoxin use will be contraindicated due to P-gp interaction based upon data from the PALLAS trial. All patients will receive oral anticoagulation for stroke prevention according to current guideline recommendations.

CHANGE AFIB will leverage several critical advantages as a pragmatic clinical trial. Data collection will be integrated into the Get With The Guidelines AFIB registry. The use of the GWTG-AFIB registry will also enhance subject recruitment and ensure the enrollment of a diverse group of patients. The randomized intervention will be compared with usual care thus further enhancing generalizability. Follow-up visits will be minimized to reduce patient burden. Moreover, follow-up visits will have "windows" to accommodate variation in follow-up intervals at different centers.

Justification for Study Drug Intervention and Dose:

Dronedarone is a non-iodinated benzofuran similar to amiodarone but is not associated with thyroid or pulmonary toxicity in randomized clinical trials or post-marketing observational studies. Dronedarone has electrophysiological characteristics spanning all 4 Vaughan-Williams anti-arrhythmic classes, with primarily class III effects. Initial trials suggested that dronedarone prolonged the time to recurrence of AF and reduced cardiovascular death and hospitalization.

The landmark ATHENA trial evaluated the efficacy and safety of dronedarone in patients with atrial arrhythmias (atrial fibrillation or atrial flutter). This trial did not include patients with a recent history of New York Heart Association (NYHA) class IV heart failure or recent hospitalization for decompensated heart failure (\<4 weeks). Approximately, 30% of the ATHENA population had NYHA class I-III heart failure. ATHENA demonstrated that dronedarone 400 mg twice daily (in combination with background therapy) reduced the combined endpoint of CV hospitalization or death from any cause by 24% (p\<0.001) compared with placebo. Of course, the ATHENA trial was not conducted in the special population of patients with a new diagnosis of AF. There are no randomized trials or guideline recommendations for antiarrhythmic therapy at the time of first-detected AF. A subgroup analysis from the ATHENA trial suggests that optimal outcomes may be achieved in those patients with shorter duration of AF (time from diagnosis). Similar observations have also been made in patients undergoing other forms of rhythm control, including catheter ablation. In this trial, patients with first-detected AF will be randomized to dronedarone on top of usual care versus usual care alone. Patients randomized to the intervention arm will be prescribed and treated with Dronedarone 400 mg bid. This dose has been chosen as it is the Food and Drug Administration approved dose as well as the dose recommended in current international guidelines. Dronedarone has also been shown to be an effective rate control agent as well. In the ERATO study treatment with dronedarone 400 mg twice daily let to a mean reduction of 24.5 beat/min in patients with permanent AF when compared with placebo. In the EURIDIS/ADONIS studies the mean difference in patients with paroxysmal/persistent AF during AF recurrence was 14 beats/min. Moreover, the dronedarone treated patients experienced improved rate control without any reduction in exercise tolerance as measured by maximal exercise.

Eligibility criteria: Inclusion Criteria:

1. Age \>=21 years.
2. First-detected atrial fibrillation (defined as atrial fibrillation diagnosed in the previous 120 days).
3. Electrocardiographic documentation of atrial fibrillation.
4. Estimated life expectancy of at least 1 year.
5. 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) and in this protocol.

Exclusion Criteria:

1. Patients with prior or planned treatment with rhythm control, either catheter ablation or chronic (\>7 days) antiarrhythmic drug therapy.

3. Planned cardiothoracic surgery. 4. New York Heart Association class III or IV heart failure or a hospitalization for heart failure in the last 4 weeks.

5. Patients with reduced ejection fraction (LVEF ≤40%). 6. Permanent atrial fibrillation. 7. Ineligible for oral anticoagulation, unless CHA2DS2-VASc is less than 3 in women or 2 in men.

8. Bradycardia with a resting heart rate \< 50 bpm 9. PR interval \>280 msec or 2nd degree or 3rd degree atrioventricular block without a permanent pacemaker/cardiac implanted electronic device.

10. Corrected QT interval \>=500 msec. 11. Pregnancy or breast feeding. 12. Severe hepatic impairment in the opinion of the investigator.

Primary outcomes:
measure: Cardiovascular Hospitalization or Death
timeFrame: Evaluated through 12 months from randomization
Secondary outcomes:
measure: Win Ratio
timeFrame: Evaluated through 12 months from randomization
measure: All-cause mortality
timeFrame: Evaluated through 12 months from randomization
measure: Ischemic stroke or systemic embolism
timeFrame: Evaluated through 12 months from randomization
measure: Hospitalization for new/worsening diagnosis of heart failure
timeFrame: Evaluated through 12 months from randomization
measure: Hospitalization for acute coronary syndrome
timeFrame: Evaluated through 12 months from randomization
measure: Time to first unplanned cardiovascular hospitalization
timeFrame: Evaluated through 12 months from randomization
measure: Unplanned cardiovascular hospitalizations--secondary analysis using Anderson-Gill extension
timeFrame: Evaluated through 12 months from randomization
Other outcomes:
measure: Any unplanned arrhythmia-related hospitalization
timeFrame: Evaluated through 12 months from randomization
measure: Number of participants who experience AF progression
timeFrame: Evaluated through 12 months from randomization
measure: Number of participants who undergo cardioversion (pharmacologic or electrical)
timeFrame: Evaluated through 12 months from randomization
measure: Number of participants who have ablation of AF (catheter, surgical or hybrid) performed
timeFrame: Evaluated through 12 months from randomization
measure: Days alive and outside of the hospital
timeFrame: Evaluated through 12 months from randomization
measure: Patient-Reported Quality of Life--AFEQT
timeFrame: At baseline and 12 months
measure: Patient-Reported Quality of Life--MAFSI
timeFrame: At baseline and 12 months
Locations:
city: Fairhope
country: United States
facility: Thomas Hospital
state: Alabama
city: Gilbert
country: United States
facility: Mercy Gilbert Medical Center
state: Arizona
city: Scottsdale
country: United States
facility: HonorHealth Scottsdale Shea Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: Los Angeles Medical Center (Kaiser Permenente)
state: California
city: Los Angeles
country: United States
facility: West Los Angeles Medical Center
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Orange
country: United States
facility: UC Irvine Medical Center (AKA UCI Health)
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Health System - Los Robles Regional Medical Center
state: California
city: Torrance
country: United States
facility: UCLA Medical Center - Harbor
state: California
city: Lakewood
country: United States
facility: Colorado Heart & Vascular Group - St. Anthony's Hospital
state: Colorado
city: Westminster
country: United States
facility: Colorado Heart & Vascular Group - St. Anthony's North Health Campus
state: Colorado
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
state: Florida
city: Miami Gardens
country: United States
facility: Ocean Wellness Center, LLC
state: Florida
city: Miami Lakes
country: United States
facility: Pharma Medical Innovations
state: Florida
city: Miami Lakes
country: United States
facility: The Angel Medical Research
state: Florida
city: Miami
country: United States
facility: Enmanuel Advanced Research Center, LLC
state: Florida
city: Miami
country: United States
facility: Life Spring Research Foundation, LLC
state: Florida
city: Miami
country: United States
facility: Nouvelle Clinical Research LLC
state: Florida
city: Miami
country: United States
facility: Golden Touch Clinical Research
state: Florida
city: Miami
country: United States
facility: Excellence Medical And Research, LLC
state: Florida
city: Miami
country: United States
facility: The Miami Research Group
state: Florida
city: Saint Petersburg
country: United States
facility: Northside Hospital
state: Florida
city: Tampa
country: United States
facility: Guardian Angel Research Center
state: Florida
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Macon
country: United States
facility: Georgia Arrhythmia Consultants and Research Institute
state: Georgia
city: Marietta
country: United States
facility: Wellstar Kennestone Hospital
state: Georgia
city: Chicago
country: United States
facility: Mt Sinai Hospital Medical Center
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Illinois Hospital
state: Illinois
city: Kankakee
country: United States
facility: Riverside Medical Center
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: North Chicago
country: United States
facility: Captain James A Lovell Federal Health Care Center
state: Illinois
city: Peoria
country: United States
facility: Proctor Community Hospital
state: Illinois
city: Peoria
country: United States
facility: Methodist Medical Center of Illinois
state: Illinois
city: Rock Island
country: United States
facility: Trinity Rock Island
state: Illinois
city: Springfield
country: United States
facility: St. Elizabeth's Hospital of the Hospital Sisters of the Third Order of St. Francis
state: Illinois
city: Springfield
country: United States
facility: St. John's Hospital of the Hospital Sisters of the Third Order of St. Francis
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Hospital, Inc.
state: Indiana
city: Indianapolis
country: United States
facility: Ascension St Vincent Hospital - Indianapolis
state: Indiana
city: Kansas City
country: United States
facility: Kansas City Heart and Vascular Specialists at Providence Medical Center
state: Kansas
city: Overland Park
country: United States
facility: Overland Park Regional Medical Center
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Lexington
country: United States
facility: Saint Joseph Hospital
state: Kentucky
city: Hammond
country: United States
facility: Heart Clinic of Hammond
state: Louisiana
city: New Orleans
country: United States
facility: Tulane Medical Center
state: Louisiana
city: Annapolis
country: United States
facility: Luminis Health Anne Arundel Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Saint Agnes Hospital
state: Maryland
city: Rockville
country: United States
facility: Adventist Healthcare Shady Grove Medical Center
state: Maryland
city: Boston
country: United States
facility: Brigham and Womens Hospital
state: Massachusetts
city: Bay City
country: United States
facility: McLaren Bay Region
state: Michigan
city: Detroit
country: United States
facility: DMC Harper University Hospital (AKA Wayne State University Hospital)
state: Michigan
city: Lansing
country: United States
facility: Sparrow Hospital
state: Michigan
city: Mount Clemens
country: United States
facility: McLaren Macomb
state: Michigan
city: Ypsilanti
country: United States
facility: Trinity Health Ann Arbor Hospital - Michigan Heart
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System
state: Minnesota
city: Columbia
country: United States
facility: University Hospital - University of Missouri
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital (AKA Washington Univ)
state: Missouri
city: Saint Louis
country: United States
facility: SSM Health Saint Louis University Hospital
state: Missouri
city: Springfield
country: United States
facility: Mercy Hospital Springfield
state: Missouri
city: Omaha
country: United States
facility: CHI Health Creighton University Medical Center - Bergan Mercy
state: Nebraska
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Bronx
country: United States
facility: NYC Health and Hospitals - Lincoln
state: New York
city: Bronx
country: United States
facility: NYC Health and Hospitals - Jacobi
state: New York
city: Bronx
country: United States
facility: NYC Health and Hospitals - North Central Bronx
state: New York
city: New York
country: United States
facility: NewYork-Presbyterian/Columbia University Irving Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering
state: New York
city: North Massapequa
country: United States
facility: DiGiovanna Institute for Medical Education & Research
state: New York
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Durham
country: United States
facility: Durham VA Health Care System
state: North Carolina
city: Raleigh
country: United States
facility: WakeMed Raleigh Campus
state: North Carolina
city: Wilmington
country: United States
facility: New Hanover Regional Medical Center
state: North Carolina
city: Minot
country: United States
facility: Trinity Hospital
state: North Dakota
city: Cleveland
country: United States
facility: The MetroHealth System
state: Ohio
city: Dayton
country: United States
facility: Kettering Health Dayton
state: Ohio
city: Dayton
country: United States
facility: Miami Valley Hospital
state: Ohio
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
city: Maumee
country: United States
facility: McLaren - St Lukes Hospital
state: Ohio
city: Wooster
country: United States
facility: Wooster Community Hospital Health System
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma City VA Health Care System
state: Oklahoma
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Camp Hill
country: United States
facility: Penn State Health Holy Spirit Medical Center
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Health Milton S Hershey Medical Center
state: Pennsylvania
city: Reading
country: United States
facility: Penn State Health St Joseph Medical Center - Main Campus
state: Pennsylvania
city: Nashville
country: United States
facility: Ascension Saint Thomas Midtown
state: Tennessee
city: Austin
country: United States
facility: Ascension Seton Medical Center Austin
state: Texas
city: Fort Worth
country: United States
facility: Texas Health Fort Worth (FKA Texas Health Harris Methodist Hospital Fort Worth)
state: Texas
city: Houston
country: United States
facility: Memorial Hermann - Texas Medical Center
state: Texas
city: McKinney
country: United States
facility: Texas Institute of Cardiology
state: Texas
city: Missouri City
country: United States
facility: Synapse Clinical Research
state: Texas
city: San Antonio
country: United States
facility: University Hospital at University of Texas San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: Richmond
country: United States
facility: Chippenham and Johnston Willis Medical Center
state: Virginia
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center (AKA Richmond VA Medical Center)
state: Virginia
city: Morgantown
country: United States
facility: JW Ruby Memorial Hospital
state: West Virginia
city: La Crosse
country: United States
facility: Mayo Clinic Hospital - Franciscan Healthcare La Crosse
state: Wisconsin
city: Madison
country: United States
facility: UW Health at the American Center (AKA UW Health East Madison Hospital)
state: Wisconsin
city: Madison
country: United States
facility: University Hospital - University of Wisconsin-Madison
state: Wisconsin
city: Marshfield
country: United States
facility: Marshfield Medical Center
state: Wisconsin
city: Weston
country: United States
facility: Marshfield Medical Center
state: Wisconsin
Study officials:
affiliation: Duke Clinical Research Organization
name: Jonathan P Piccini, MD, MHS
role: PRINCIPAL_INVESTIGATOR
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