The Effect of Beta-blocker on Chronotropic Response and Cardiorespiratory Fitness in Patients With Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

The Effect of Beta-blocker on Chronotropic Response and Cardiorespiratory Fitness in Patients With Atrial Fibrillation: a Crossover Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05332457
• Other study ID #: 202201028MINB
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2023
• Source: National Taiwan University Hospital
• Contact: Hung-Jui Chuang, MD
• Phone: 00886-2-23123456
• Email: 103311[@]ntuh.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Reduced dosage of beta-blocker
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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.