Back to resultsAtrial Fibrillation: Chronic Beta-blocker Use Versus As-needed Rate Control Guided by Implantable Cardiac Monitor
Primary Purpose
Atrial Fibrillation, Diastolic Dysfunction, HFpEF - Heart Failure With Preserved Ejection Fraction
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
As needed pharmacological rate control with beta-blocker (metoprolol tartrate, metoprolol succinate) or calcium channel blocker (diltiazem, verapamil)
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring AF, HFpEF, Exercise capacity, Peak oxygen consumption, Beta Blocker
Eligibility Criteria
Inclusion Criteria: Paroxysmal or persistent AF diagnosed in the past 4 weeks or longer Implantable cardiac monitor (either loop recorder or pacemaker) Current treatment with greater than minimum doses of beta-blockers OR any beta-blocker with resting sinus rhythm heart rate < 75 bpm (documented on EKG in the last 6 months OR at enrollment visit) Left ventricular ejection fraction ≥ 50% (reported on echocardiogram within the past 48 months) Echocardiographic evidence of structural changes consistent with HFpEF defined by (1) left ventricular hypertrophy (septal or posterior wall thickness > 10mm) OR (2) left atrial enlargement OR (3) diastolic dysfunction. Exclusion Criteria: Long-standing persistent or permanent atrial fibrillation (Long-standing persistent AF is defined as continuous AF of > 12 months duration. Permanent AF is defined as AF accepted by the patient and physician and no further attempts to restore/maintain sinus rhythm will be undertaken). Echocardiographic evidence of left ventricular dilation (defined as left ventricular end diastolic volume (LVEDV) index ≥ 80ml/m2 as determined by echocardiogram within the past 48 months. Documentation in the electronic medical record suggesting a life expectancy less than 12 months Minimum dosage of beta-blocker therapy to meet enrollment criterion: Metoprolol tartrate 25mg twice daily, Metoprolol succinate 50mg daily, Carvedilol 12.5mg daily, Bisoprolol 5mg twice daily, Nebivolol 5mg daily, Atenolol 50mg daily, Labetalol 100mg twice daily, Propranolol 40mg twice daily
Sites / Locations
- University of Vermont Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
As needed rate control
Arm Description
Patients randomized to the control arm will continue taking their daily beta-blocker for rate control of atrial fibrillation
Patients randomized to the experimental arm will stop their daily beta-blocker and take as needed rate control guided by their implantable cardiac monitor
Outcomes
Primary Outcome Measures
Exercise capacity
Change in peak oxygen consumption during cardiopulmonary exercise testing
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05745337
First Posted
January 30, 2023
Last Updated
February 28, 2023
Sponsor
University of Vermont
1. Study Identification
Unique Protocol Identification Number
NCT05745337
Brief Title
Atrial Fibrillation: Chronic Beta-blocker Use Versus As-needed Rate Control Guided by Implantable Cardiac Monitor
Official Title
Improving Outcomes in Atrial Fibrillation Patients Aided by Implantable Cardiac Monitor: Evaluation of Chronic Beta-blocker Use Versus As-needed Pharmacological Rate Control
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Diastolic Dysfunction, HFpEF - Heart Failure With Preserved Ejection Fraction
Keywords
AF, HFpEF, Exercise capacity, Peak oxygen consumption, Beta Blocker
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients randomized to the control arm will continue taking their daily beta-blocker for rate control of atrial fibrillation
Arm Title
As needed rate control
Arm Type
Experimental
Arm Description
Patients randomized to the experimental arm will stop their daily beta-blocker and take as needed rate control guided by their implantable cardiac monitor
Intervention Type
Drug
Intervention Name(s)
As needed pharmacological rate control with beta-blocker (metoprolol tartrate, metoprolol succinate) or calcium channel blocker (diltiazem, verapamil)
Intervention Description
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
Primary Outcome Measure Information:
Title
Exercise capacity
Description
Change in peak oxygen consumption during cardiopulmonary exercise testing
Time Frame
At time of randomization and 6 months afterwards.
Secondary Outcome Measure Information:
Title
Number of participants with a composite of treatment related adverse events
Description
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
Other Pre-specified Outcome Measures:
Title
Number of participants with a composite of treatment related heart failure events
Description
Heart failure events: diuretic drug change, emergency room visit
Time Frame
At 6 months, at 12 months, at 18 months, at 24 months
Title
Number of participants with a composite of treatment related atrial fibrillation events
Description
Atrial fibrillation events: planned hospitalization, emergency room visit, cardioversion, antiarrhythmic medication initiation
Time Frame
At 6 months, at 12 months, at 18 months, at 24 months
Title
Change in quality of life by Minnesota Living with heart failure questionnaire score
Description
Score ranges from 0-105 with higher scores meaning worse quality of life
Time Frame
At time of randomization and 6 months afterwards.
Title
Change in quality of life by Atrial fibrillation Effect on Quality of life questionnaire score
Description
Score ranges from 0-100 with higher scores meaning better quality of life
Time Frame
At time of randomization and 6 months afterwards.
Title
Change in NTproBNP
Time Frame
At time of randomization and 6 months afterwards.
Title
Change in hsTroponin
Time Frame
At time of randomization and 6 months afterwards.
Title
Change in HbA1c
Time Frame
At time of randomization and 6 months afterwards.
Title
Change in Fructosamine
Time Frame
At time of randomization and 6 months afterwards.
Title
Change in Cystatin C
Time Frame
At time of randomization and 6 months afterwards.
Title
Change in atrial fibrillation burden recorded by implantable cardiac monitor
Time Frame
At time of randomization and 6 months afterwards.
Title
Change in 6 minute walk distance
Time Frame
At time of randomization and 6 months afterwards.
Title
Change in device detected activity level
Time Frame
At time of randomization and 6 months afterwards.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Paroxysmal or persistent AF diagnosed in the past 4 weeks or longer
Implantable cardiac monitor (either loop recorder or pacemaker)
Current treatment with greater than minimum doses of beta-blockers OR any beta-blocker with resting sinus rhythm heart rate < 75 bpm (documented on EKG in the last 6 months OR at enrollment visit)
Left ventricular ejection fraction ≥ 50% (reported on echocardiogram within the past 48 months)
Echocardiographic evidence of structural changes consistent with HFpEF defined by (1) left ventricular hypertrophy (septal or posterior wall thickness > 10mm) OR (2) left atrial enlargement OR (3) diastolic dysfunction.
Exclusion Criteria:
Long-standing persistent or permanent atrial fibrillation (Long-standing persistent AF is defined as continuous AF of > 12 months duration. Permanent AF is defined as AF accepted by the patient and physician and no further attempts to restore/maintain sinus rhythm will be undertaken).
Echocardiographic evidence of left ventricular dilation (defined as left ventricular end diastolic volume (LVEDV) index ≥ 80ml/m2 as determined by echocardiogram within the past 48 months.
Documentation in the electronic medical record suggesting a life expectancy less than 12 months
Minimum dosage of beta-blocker therapy to meet enrollment criterion:
Metoprolol tartrate 25mg twice daily, Metoprolol succinate 50mg daily, Carvedilol 12.5mg daily, Bisoprolol 5mg twice daily, Nebivolol 5mg daily, Atenolol 50mg daily, Labetalol 100mg twice daily, Propranolol 40mg twice daily
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Habel, MD
Phone
8028470000
Email
nicole.habel@uvmhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Henderson
Email
amy.henderson@uvmhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Habel, MD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Habel, MD
Email
nicole.habel@uvmhealth.org
12. IPD Sharing Statement
Plan to Share IPD
No
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Atrial Fibrillation: Chronic Beta-blocker Use Versus As-needed Rate Control Guided by Implantable Cardiac Monitor
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