The goal of this study is to test the feasibility of guiding as-needed pharmacological rate control of atrial fibrillation (AF) by implantable cardiac monitors and to assess the impact of continuous beta-blocker therapy versus as-needed rate control on the following outcomes: (1) exercise capacity, (2) AF burden, (3) symptomatic heart failure, (4) biomarker assessment of cardiac filling pressures and cardio-metabolic health, and (5) quality of life in patients with atrial fibrillation and stage II or III heart failure with preserved ejection fraction.
Patients ≥ 18 years of age with paroxysmal or persistent AF who have an implantable cardiac monitor (either loop recorder or pacemaker) and who are receiving daily beta-blocker therapy will be screened for meeting the inclusion/exclusion criteria. Trial participants will then be randomized into the daily beta-blocker or as-needed pharmacological rate control. At baseline and six months trial participants will undergo assessment of the following measures: * Assessment of Quality of life using the Minnesota Living with Heart Failure Questionnaire and the Atrial Fibrillation Effect on Quality of life Questionnaire. * Blood draw * Cardiopulmonary exercise test, 6 Minute Walk Test and average daily activity level via integrated accelerometer of the implantable cardiac monitor (if available). * Assessment of AF burden Study participants may opt into long-term follow up visits at 12, 18 and 24 months. Chart review will continue for up to 4 years after enrollment for the purpose of monitoring clinical endpoints: * Heart failure events (diuretic drug change, emergency room visit, hospitalization) * AF events (hospitalization, emergency room visit, cardioversion, antiarrhythmic medication initiation) * Stroke or transient ischemic attack * Myocardial infarction
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Patients will stop their daily beta-blocker and take as-needed rate control (beta-blocker or calcium channel blocker) guided by their implantable cardiac monitor
University of Vermont Medical Center
Burlington, Vermont, United States
RECRUITINGExercise capacity
Change in peak oxygen consumption during cardiopulmonary exercise testing
Time frame: At time of randomization and 6 months afterwards.
Number of participants with a composite of treatment related adverse events
Number of heart failure hospitalization, unplanned hospitalization for atrial fibrillation, stroke or transient ischemic attack, acute coronary syndrome in both treatment arms
Time frame: At 6 months, at 12 months, at 18 months, at 24 months
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