Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05745337
Status:
RECRUITING
Last Update Posted:
2023-03-03
First Post:
2023-01-30
Brief Title:
Atrial Fibrillation Chronic Beta-blocker Use Versus As-needed Rate Control Guided by Implantable Cardiac Monitor
Sponsor:
University of Vermont
Organization:
University of Vermont
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 inclusionexclusion 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None