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NCT Number: NCT05332457

The Effect of Beta-blocker on Chronotropic Response and Cardiorespiratory Fitness in Patients With Atrial Fibrillation

This is a prospective study to evaluate changes in exercise capacity and chronotropic response to exercise before and after beta-blocker dosage reduction in patients with atrial fibrillation (AF).

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location status: Recruiting

Location contact

Hung-Jui Chuang, MD

CONTACT

[email protected]

00886-2-23123456 ext. 67034

About this study

Rate control therapy is the first-line treatment for atrial fibrillation (AF). Resting heart rate(HR) is the treatment target of rate control therapy in current clinical practice; However, the optimal value for resting heart rate in AF remained unclear. Beta-blocker(BB) is widely used as rate-control agent. It is concerned that excessive use of BB might lead to a negative effect on exercise capacity in patients with AF. The aim of this study is to explore the effect of Beta-blocker on hemodynamic parameters and peak oxygen uptake during cardiopulmonary exercise test (CPET).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • > 20 years of age.
  • Clinically stable patients with persistent atrial fibrillation using beta-blocker as rate-control agent without dosage adjustment for at least 3 months.
  • Resting heart rate < 80 bpm.
  • Left ventricular ejection fraction > 50%.

Exclusion criteria

  • Beta-blocker usage due to indications other than rate control for atrial fibrillation.
  • Inability to perform a cardiopulmonary exercise testing.
  • Presence of contraindications for cardiopulmonary exercise testing according to the American College of Sports Medicine's Guidelines for Exercise Testing and Prescription.
  • Patients with implantable cardioverter defibrillator or pacemaker.
  • Pregnancy.
  • Inability to provide informed consent.

Treatment and study plan

Reduced dosage of beta-blocker

Drug

Phase I:

  • CPET performed at trough BB concentration: participants will undergo CPET at least 30 hours after last beta-blocker usage.
  • CPET performed at peak BB concentration : participants will undergo CPET at 3 hours after last beta-blocker usage.

Phase II:

BB dosage will be reduced.

Primary outcomes

  1. Peak oxygen intake

    Time frame: The change in peak oxygen uptake will be measured at day 0 , day 7 and day 21.

    Peak oxygen intake will be assessed with symptom-limited cardiopulmonary exercise testing.

  2. Chronotropic response to exercise

    Time frame: The change in chronotropic response to exercise will be measured at day 0 , day 7 and day 21.

    Plasma norepinephrine level was obtained before and immediately after cardiopulmonary exercise testing to assess the relationship of beta-blocker, circulating norepinephrine level and chronotropic response to exercise.

Secondary outcomes

  1. European Heart Rhythm Association (EHRA) symptom scale

    Time frame: The change in European Heart Rhythm Association (EHRA) score will be measured at day 0 , day 7 and day 21.

    The investigators will assess the change in EHRA symptom scale. The EHRA score ranges from 1 to 4. Higher scores indicate more severe symptoms.

  2. Cardiac output and stroke volume

    Time frame: The change in cardiac output and stroke volume will be measured at day 0 , day 7 and day 21.

    Cardiac output and stroke volume during incremental exercise testing will be assessed by impedance cardiography.

  3. Cognitive function

    Time frame: The change in MoCA will be measured at day 0 , day 7 and day 21.

    The investigators will assess the change in Montreal Cognitive Assessment (MoCA). The total score of MoCA ranges from 0 to 30. Higher scores indicate better cognitive function.

  4. NT-proBNP

    Time frame: The change in NT-proBNP will be measured at day 0 , day 7 and day 21.

    NT-proBNP level will be assessed before and immediate after the cardiopulmonary exercise test.

  5. Quality of life evaluation

    Time frame: The change in SF-36 will be measured at day 0 , day 7 and day 21.

    The investigators will assess the change in 36-Item Short Form Survey (SF-36). SF-36 consists of eight domains of health status. The score of each domain ranges from 0 to 100. Higher scores indicate a better outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Hung-Jui Chuang, MD

CONTACT

[email protected]

00886-2-23123456 ext. 67034

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

The Effect of Beta-blocker on Chronotropic Response and Cardiorespiratory Fitness in Patients With Atrial Fibrillation: a Crossover Randomized Controlled Trial.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 18, 2022
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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