Clinical trial NCT05332457: The Effect of Beta-blocker on Chronotropic Response and Cardiorespiratory Fitness in Patients With Atrial Fibrillation
Official title: The Effect of Beta-blocker on Chronotropic Response and Cardiorespiratory Fitness in Patients With Atrial Fibrillation: a Crossover Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Beta-blocker
Chronotropic response
Cardiorespiratory fitness
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a prospective, single-centered, crossover, randomized (1:1) study.
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Peak oxygen intake
timeFrame: The change in peak oxygen uptake will be measured at day 0 , day 7 and day 21.
measure: Chronotropic response to exercise
timeFrame: The change in chronotropic response to exercise will be measured at day 0 , day 7 and day 21.
Secondary outcomes:
measure: European Heart Rhythm Association (EHRA) symptom scale
timeFrame: The change in European Heart Rhythm Association (EHRA) score will be measured at day 0 , day 7 and day 21.
measure: Cardiac output and stroke volume
timeFrame: The change in cardiac output and stroke volume will be measured at day 0 , day 7 and day 21.
measure: Cognitive function
timeFrame: The change in MoCA will be measured at day 0 , day 7 and day 21.
measure: NT-proBNP
timeFrame: The change in NT-proBNP will be measured at day 0 , day 7 and day 21.
measure: Quality of life evaluation
timeFrame: The change in SF-36 will be measured at day 0 , day 7 and day 21.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
name: Hung-Jui Chuang, MD
role: PRINCIPAL_INVESTIGATOR
References: