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

NCT05332457 | Recruiting

• 1 other identifier: 202201028MINB
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Beta-blocker; Chronotropic response; Cardiorespiratory fitness

Outcome Measures

Primary Outcomes (2)

• Peak oxygen intake

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

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

• Chronotropic response to exercise

  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.

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

Secondary Outcomes (5)

• European Heart Rhythm Association (EHRA) symptom scale

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

• Cardiac output and stroke volume

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

• Cognitive function

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

• NT-proBNP

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

• Quality of life evaluation

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

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Phase I : Participants will undergo first CPET (Day 0) at trough concentration of BB. After 7-day regular usage of BB, the second CPET(Day 7) will be performed at peak concentration of BB. Participants will enter the second phase if the results of CPET fulfill the pre-determined conditions as follows: (1) Chronotropic index \< 0.8 at peak level of BB, (2) Resting HR \< 110 bpm at trough level of BB, (3) Absent of unstable arrhythmia or unstable hemodynamics during CPET at trough level. Phase II: BB dosage will be reduced. Daily blood pressure, heart rate and adverse event will be recorded. If participants remained clinically stable, the third CPET(Day 21) will be performed 14 days after the reduction of dosage. If participants' resting heart rate exceed 110 bpm, the dosage will be adjusted to the original level.

Drug: Reduced dosage of beta-blocker

Arm B

ACTIVE COMPARATOR

Phase I : Participants will undergo first CPET(Day 0) at peak concentration of BB. After 7-day regular usage of BB, the second CPET(Day 7) will be performed at trough concentration of BB. Participants will enter the second phase if the results of CPET fulfill the pre-determined conditions as follows: (1) Chronotropic index \< 0.8 at peak level of BB, (2) Resting HR \< 110 bpm at trough level of BB, (3) Absent of unstable arrhythmia or unstable hemodynamics during CPET at trough level. Phase II: BB dosage will be reduced. Daily blood pressure, heart rate and adverse event will be recorded. If participants remained clinically stable, the third CPET(Day 21) will be performed 14 days after the reduction of dosage. If participants' resting heart rate exceed 110 bpm, the dosage will be adjusted to the original level.

Drug: Reduced dosage of beta-blocker

Interventions

Reduced dosage of beta-blocker DRUG

Phase I: 1. CPET performed at trough BB concentration: participants will undergo CPET at least 30 hours after last beta-blocker usage. 2. 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.

Arm A; Arm B

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Hung-Jui Chuang, MD

  Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hung-Jui Chuang, MD

CONTACT

00886-2-23123456; 103311@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor are blinked to participants' allocation group.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, single-centered, crossover, randomized (1:1) study.

Study Record Dates

• First Submitted: April 10, 2022
• First Posted: April 18, 2022
• Study Start: July 1, 2025
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)