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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduced dosage of beta-blocker | Drug | Phase I:
Phase II: BB dosage will be reduced. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| European Heart Rhythm Association (EHRA) symptom scale | The investigators will assess the change in EHRA symptom scale. The EHRA score ranges from 1 to 4. Higher scores indicate more severe symptoms. | The change in European Heart Rhythm Association (EHRA) score will be measured at day 0 , day 7 and day 21. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hung-Jui Chuang, MD | Contact | 00886-2-23123456 | 67034 | 103311@ntuh.gov.tw |
| Name | Affiliation | Role |
|---|---|---|
| Hung-Jui Chuang, MD | Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | 100 | Taiwan |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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This is a prospective, single-centered, crossover, randomized (1:1) study.
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The outcome assessor are blinked to participants' allocation group.
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| Cardiac output and stroke volume |
Cardiac output and stroke volume during incremental exercise testing will be assessed by impedance cardiography. |
| The change in cardiac output and stroke volume will be measured at day 0 , day 7 and day 21. |
| Cognitive function | 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. | The change in MoCA will be measured at day 0 , day 7 and day 21. |
| NT-proBNP | NT-proBNP level will be assessed before and immediate after the cardiopulmonary exercise test. | The change in NT-proBNP will be measured at day 0 , day 7 and day 21. |
| Quality of life evaluation | 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. | The change in SF-36 will be measured at day 0 , day 7 and day 21. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |