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

Back to results

Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Reduced dosage of beta-blocker

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Beta-blocker, Chronotropic response, Cardiorespiratory fitness

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Peak oxygen intake

Peak oxygen intake will be assessed with symptom-limited cardiopulmonary exercise testing.

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.

Secondary Outcome Measures

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.

Cardiac output and stroke volume

Cardiac output and stroke volume during incremental exercise testing will be assessed by impedance cardiography.

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.

NT-proBNP

NT-proBNP level will be assessed before and immediate after the cardiopulmonary exercise test.

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.

Full Information

NCT ID

NCT05332457

First Posted

April 10, 2022

Last Updated

April 19, 2022

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05332457

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

Atrial Fibrillation, Beta-blocker, Chronotropic response, Cardiorespiratory fitness

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

This is a prospective, single-centered, crossover, randomized (1:1) study.

Masking

Outcomes Assessor

Masking Description

The outcome assessor are blinked to participants' allocation group.

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Arm B

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Reduced dosage of beta-blocker

Intervention Description

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.

Primary Outcome Measure Information:

Title

Peak oxygen intake

Description

Peak oxygen intake will be assessed with symptom-limited cardiopulmonary exercise testing.

Time Frame

The change in peak oxygen uptake will be measured at day 0 , day 7 and day 21.

Title

Chronotropic response to exercise

Description

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.

Time Frame

The change in chronotropic response to exercise will be measured at day 0 , day 7 and day 21.

Secondary Outcome Measure Information:

Title

European Heart Rhythm Association (EHRA) symptom scale

Description

The investigators will assess the change in EHRA symptom scale. The EHRA score ranges from 1 to 4. Higher scores indicate more severe symptoms.

Time Frame

The change in European Heart Rhythm Association (EHRA) score will be measured at day 0 , day 7 and day 21.

Title

Cardiac output and stroke volume

Description

Cardiac output and stroke volume during incremental exercise testing will be assessed by impedance cardiography.

Time Frame

The change in cardiac output and stroke volume will be measured at day 0 , day 7 and day 21.

Title

Cognitive function

Description

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.

Time Frame

The change in MoCA will be measured at day 0 , day 7 and day 21.

Title

NT-proBNP

Description

NT-proBNP level will be assessed before and immediate after the cardiopulmonary exercise test.

Time Frame

The change in NT-proBNP will be measured at day 0 , day 7 and day 21.

Title

Quality of life evaluation

Description

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.

Time Frame

The change in SF-36 will be measured at day 0 , day 7 and day 21.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

No

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hung-Jui Chuang, MD

Phone

00886-2-23123456

Ext

67034

Email

103311@ntuh.gov.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hung-Jui Chuang, MD

Organizational Affiliation

Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hung-Jui Chuang, MD

Phone

00886-2-23123456

Ext

67034

Email

103311@ntuh.gov.tw

12. IPD Sharing Statement

Plan to Share IPD

No

Atrial Fibrillation

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial