Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation, Beta-blocker, Chronotropic response, Cardiorespiratory fitness
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).
Interventions
DRUGReduced 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.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessor are blinked to participants' allocation group.
Intervention model description
This is a prospective, single-centered, crossover, randomized (1:1) study.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak oxygen intake | 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. |
| Chronotropic response to exercise | 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
| Measure | Time frame | Description |
|---|---|---|
| Cognitive function | 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. |
| 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. | The investigators will assess the change in EHRA symptom scale. The EHRA score ranges from 1 to 4. Higher scores indicate more severe symptoms. |
| Quality of life evaluation | 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. |
| NT-proBNP | 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. |
| Cardiac output and stroke volume | 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. |
Countries
Taiwan
Contacts
Primary ContactHung-Jui Chuang, MD
Outcome results
None listed