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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT05745337
Study type Interventional
Source University of Vermont
Contact Nicole Habel, MD
Phone 8028470000
Email nicole.habel@uvmhealth.org
Status Recruiting
Phase Phase 1
Start date February 6, 2023
Completion date December 31, 2025

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