Atrial Fibrillation: Chronic Beta-blocker Use Versus As-needed Rate

Status Recruiting

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

Clinical Trial Details

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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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Atrial Fibrillation: Chronic Beta-blocker Use Versus As-needed Rate Control Guided by Implantable Cardiac Monitor

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms