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

NCT ID: NCT05332457

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2025-12-31

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).

Detailed Description

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).

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm A

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.

Group Type: ACTIVE_COMPARATOR

Reduced dosage of beta-blocker

Intervention Type: 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 B

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.

Group Type: ACTIVE_COMPARATOR

Reduced dosage of beta-blocker

Intervention Type: 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.

Interventions

Reduced dosage of beta-blocker

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. > 20 years of age.

2. Clinically stable patients with persistent atrial fibrillation using beta-blocker as rate-control agent without dosage adjustment for at least 3 months.

3. Resting heart rate < 80 bpm.

4. Left ventricular ejection fraction > 50%.

Exclusion Criteria

1. Beta-blocker usage due to indications other than rate control for atrial fibrillation.

2. Inability to perform a cardiopulmonary exercise testing.

3. Presence of contraindications for cardiopulmonary exercise testing according to the American College of Sports Medicine's Guidelines for Exercise Testing and Prescription.

4. Patients with implantable cardioverter defibrillator or pacemaker.

5. Pregnancy.

6. Inability to provide informed consent.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hung-Jui Chuang, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Hung-Jui Chuang, MD

Role: CONTACT

103311@ntuh.gov.tw

00886-2-23123456 ext. 67034

Facility Contacts

Hung-Jui Chuang, MD

Role: primary

103311@ntuh.gov.tw

00886-2-23123456 ext. 67034

Other Identifiers

202201028MINB

Identifier Type: -

Identifier Source: org_study_id