The Effect of Beta-blocker on Chronotropic Response and Cardiorespiratory Fitness in Patients With Atrial Fibrillation
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Reduced dosage of beta-blocker.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Beta-blocker on Chronotropic Response and Cardiorespiratory Fitness in Patients With Atrial Fibrillation: a Crossover Randomized Controlled Trial.
Overview
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
- Drug 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.
Primary outcome measures
- Peak oxygen intake [Time frame: The change in peak oxygen uptake will be measured at day 0 , day 7 and day 21.]
- Chronotropic response to exercise [Time frame: The change in chronotropic response to exercise will be measured at day 0 , day 7 and day 21.]
Secondary outcome measures (5)
- 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.]
Eligibility criteria
Inclusion criteria
- > 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%.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- National Taiwan University Hospital — Taipei
Identifiers
NCT: NCT05332457 · 202201028MINB