Rate Control in Patients With Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— RaP-AF  

Official title:

The Surrogate Marker of Rate Control in Patients With Atrial Fibrillation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04513509
• Other study ID #: 202006205RIND
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 7, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2020
• Source: National Taiwan University Hospital
• Contact: Chih-Chieh Yu, MD.PhD
• Phone: +886-2-23123456
• Email: sweetchieh[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To search for the best marker for the patients in atrial fibrillation with rate control

Description:

In an aging society, the prevalence of atrial fibrillation is increasing. The main treatment strategy is to reduce the complications of embolic stroke and heart failure. Among these patients, a group of them will choose to have "rate control" based on the heart conditions and the preference of the patients. The strategy is to control the ventricular rate by drugs to prevent the heart from failure. However, when the physicians attempt to do so, they encounter two questions: how much is the optimal drug dose? And what is the best marker we are looking to? To answer these questions, the investigators design a prospective, cross-over study to explore this issue. The participants will do cardiopulmonary exercise test (CPET) before and after treatment. They will receive another CPET if drug dose is titrated up. With the study, the investigators will understand whether a resting heart rate can be a good marker for optimal drug dosage, and what is the optimal range of heart rate the physicians should target.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

1. 20~90 years old

2. Rate control is preferred after shared decision making

Exclusion Criteria:

1. cannot cooperate with or complete CPET

2. has contraindication for CPET, such as uncontrolled heart failure, hypertension, angina, valvular heart disease, lung function impariment that SaO2<90% at room air.

3. Ventricular rate below 80/min before any medication

4. Permanent pacemaker implanted

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiopulmonary Exercise Test
• Rate Control

Intervention

Drug:
• Atenolol, Bisoprolol, Metoprolol, Nebivolol, Propranolol, Diltiazem, Verapamil, digoxin
Start with empirical lower dose for 3 months, and then titrate up

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	Change of Maximal Oxygen consumption	acquire the data by Cardiopulmonary exercise test (CPET) with different (low and high) drug dosages for rate control	0, 3, 6 months