Atrial FibrillationNCT05332457
The Effect of Beta-blocker on Chronotropic Response and Cardiorespiratory Fitness in Patients With Atrial Fibrillation
A study testing Reduced dosage of beta-blocker in people with Atrial Fibrillation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Reduced dosage of beta-blocker
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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%.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Hung-Jui Chuang, MD, 00886-2-23123456 ext. 67034, 103311@ntuh.gov.tw
About this study
Official title: The Effect of Beta-blocker on Chronotropic Response and Cardiorespiratory Fitness in Patients With Atrial Fibrillation: a Crossover Randomized Controlled Trial.
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).
Read the 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
- Being tested
- Reduced dosage of beta-blocker
- Keywords
- Atrial Fibrillation, Beta-blocker, Chronotropic response, Cardiorespiratory fitness
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced dosage of beta-blockerDrug
Phase I:
- CPET performed at trough BB concentration: participants will undergo CPET at least 30 hours after last beta-blocker usage.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Reduced dosage of beta-blocker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen intake
Peak oxygen intake will be assessed with symptom-limited cardiopulmonary exercise testing.
Measured: 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.
Measured: 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 investigators will assess the change in EHRA symptom scale. The EHRA score ranges from 1 to 4. Higher scores indicate more severe symptoms.
Measured: 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
Cardiac output and stroke volume during incremental exercise testing will be assessed by impedance cardiography.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The change in SF-36 will be measured at day 0 , day 7 and day 21.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start1 Jul 2025 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a prospective, single-centered, crossover, randomized (1:1) study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hung-Jui Chuang, MD, Principal investigator, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332457
- Sponsor's protocol ID
- 202201028MINB
- Status last verified
- Mar 2025
- First submitted
- 10 Apr 2022
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Beta-blocker on Chronotropic Response and Cardiorespiratory Fitness in Patients With Atrial Fibrillation: a Crossover Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05332457
- Acronym / sponsor ID
- 202201028MINB
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Beta-blocker, Chronotropic response, Cardiorespiratory fitness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, single-centered, crossover, randomized (1:1) study.
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: Reduced dosage of beta-blockerPhase 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. |
| Arm B | Active comparator | Drug: Reduced dosage of beta-blockerPhase 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 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%.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduced dosage of beta-blockerPhase 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. | Drug | Arm A, Arm B |
Primary outcome
Peak oxygen intake
Time frame: 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
Time frame: 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.
5 secondary outcomes
European Heart Rhythm Association (EHRA) symptom scale
Time frame: 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
Time frame: The change in cardiac output and stroke volume will be measured at day 0 , day 7 and day 21.
Cognitive function
Time frame: The change in MoCA will be measured at day 0 , day 7 and day 21.
NT-proBNP
Time frame: The change in NT-proBNP will be measured at day 0 , day 7 and day 21.
Quality of life evaluation
Time frame: The change in SF-36 will be measured at day 0 , day 7 and day 21.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hung-Jui Chuang, MD principal investigator
Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced dosage of beta-blocker in people with Atrial Fibrillation, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hung-Jui Chuang, MD (00886-2-23123456 ext. 67034, 103311@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen intake (time frame: The change in peak oxygen uptake will be measured at day 0 , day 7 and day 21.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.