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

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ClinicalTrials.gov Identifier: NCT05745337
Recruitment Status : Recruiting
First Posted : February 27, 2023
Last Update Posted : March 3, 2023
Sponsor:
Information provided by (Responsible Party):
Nicole Habel, MD, University of Vermont

Study Description
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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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Diastolic Dysfunction HFpEF - Heart Failure With Preserved Ejection Fraction Drug: As needed pharmacological rate control with beta-blocker (metoprolol tartrate, metoprolol succinate) or calcium channel blocker (diltiazem, verapamil) Phase 1

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 6, 2023
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control
Patients randomized to the control arm will continue taking their daily beta-blocker for rate control of atrial fibrillation
Experimental: As needed rate control
Patients randomized to the experimental arm will stop their daily beta-blocker and take as needed rate control guided by their implantable cardiac monitor
 Drug: As needed pharmacological rate control with beta-blocker (metoprolol tartrate, metoprolol succinate) or calcium channel blocker (diltiazem, verapamil)
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


Outcome Measures
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Primary Outcome Measures :
  1. Exercise capacity [ Time Frame: At time of randomization and 6 months afterwards. ]
    Change in peak oxygen consumption during cardiopulmonary exercise testing


Secondary Outcome Measures :
  1. Number of participants with a composite of treatment related adverse events [ Time Frame: At 6 months, at 12 months, at 18 months, at 24 months ]
    Number of heart failure hospitalization, unplanned hospitalization for atrial fibrillation, stroke or transient ischemic attack, acute coronary syndrome in both treatment arms


Other Outcome Measures:
  1. Number of participants with a composite of treatment related heart failure events [ Time Frame: At 6 months, at 12 months, at 18 months, at 24 months ]
    Heart failure events: diuretic drug change, emergency room visit

  2. Number of participants with a composite of treatment related atrial fibrillation events [ Time Frame: At 6 months, at 12 months, at 18 months, at 24 months ]
    Atrial fibrillation events: planned hospitalization, emergency room visit, cardioversion, antiarrhythmic medication initiation

  3. Change in quality of life by Minnesota Living with heart failure questionnaire score [ Time Frame: At time of randomization and 6 months afterwards. ]
    Score ranges from 0-105 with higher scores meaning worse quality of life

  4. Change in quality of life by Atrial fibrillation Effect on Quality of life questionnaire score [ Time Frame: At time of randomization and 6 months afterwards. ]
    Score ranges from 0-100 with higher scores meaning better quality of life

  5. Change in NTproBNP [ Time Frame: At time of randomization and 6 months afterwards. ]
  6. Change in hsTroponin [ Time Frame: At time of randomization and 6 months afterwards. ]
  7. Change in HbA1c [ Time Frame: At time of randomization and 6 months afterwards. ]
  8. Change in Fructosamine [ Time Frame: At time of randomization and 6 months afterwards. ]
  9. Change in Cystatin C [ Time Frame: At time of randomization and 6 months afterwards. ]
  10. Change in atrial fibrillation burden recorded by implantable cardiac monitor [ Time Frame: At time of randomization and 6 months afterwards. ]
  11. Change in 6 minute walk distance [ Time Frame: At time of randomization and 6 months afterwards. ]
  12. Change in device detected activity level [ Time Frame: At time of randomization and 6 months afterwards. ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05745337


Contacts
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Contact: Nicole Habel, MD 8028470000 nicole.habel@uvmhealth.org
Contact: Amy Henderson amy.henderson@uvmhealth.org

Locations
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United States, Vermont
University of Vermont Medical Center Recruiting
Burlington, Vermont, United States, 05405
Contact: Nicole Habel, MD       nicole.habel@uvmhealth.org   
Sponsors and Collaborators
University of Vermont
Investigators
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Principal Investigator: Nicole Habel, MD University of Vermont
More Information
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Publications:
Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available. Erratum In: Eur Heart J. 2021 Feb 1;42(5):507. Eur Heart J. 2021 Feb 1;42(5):546-547. Eur Heart J. 2021 Oct 21;42(40):4194.
Solomon SD, Rizkala AR, Lefkowitz MP, Shi VC, Gong J, Anavekar N, Anker SD, Arango JL, Arenas JL, Atar D, Ben-Gal T, Boytsov SA, Chen CH, Chopra VK, Cleland J, Comin-Colet J, Duengen HD, Echeverria Correa LE, Filippatos G, Flammer AJ, Galinier M, Godoy A, Goncalvesova E, Janssens S, Katova T, Kober L, Lelonek M, Linssen G, Lund LH, O'Meara E, Merkely B, Milicic D, Oh BH, Perrone SV, Ranjith N, Saito Y, Saraiva JF, Shah S, Seferovic PM, Senni M, Sibulo AS Jr, Sim D, Sweitzer NK, Taurio J, Vinereanu D, Vrtovec B, Widimsky J Jr, Yilmaz MB, Zhou J, Zweiker R, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, Van Veldhuisen DJ, Zannad F, Zile MR, McMurray JJV. Baseline Characteristics of Patients With Heart Failure and Preserved Ejection Fraction in the PARAGON-HF Trial. Circ Heart Fail. 2018 Jul;11(7):e004962. doi: 10.1161/CIRCHEARTFAILURE.118.004962.

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Responsible Party: Nicole Habel, MD, Principal Investigator, University of Vermont
ClinicalTrials.gov Identifier: NCT05745337    
Other Study ID Numbers: 00002271
First Posted: February 27, 2023    Key Record Dates
Last Update Posted: March 3, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Nicole Habel, MD, University of Vermont:
AF
HFpEF
Exercise capacity
Peak oxygen consumption
Beta Blocker
Additional relevant MeSH terms:
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Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Metoprolol
Verapamil
Diltiazem
Calcium Channel Blockers
Calcium
Adrenergic beta-Antagonists
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
 Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Membrane Transport Modulators
Vasodilator Agents