Rate Control in Patients With Atrial Fibrillation (RaP-AF)
Primary Purpose
Atrial Fibrillation, Rate Control, Cardiopulmonary Exercise Test
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Atenolol, Bisoprolol, Metoprolol, Nebivolol, Propranolol, Diltiazem, Verapamil, digoxin
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, rate control, cardiopulmonary exercise test
Eligibility Criteria
Inclusion Criteria:
- 20~90 years old
- Rate control is preferred after shared decision making
Exclusion Criteria:
- cannot cooperate with or complete CPET
- has contraindication for CPET, such as uncontrolled heart failure, hypertension, angina, valvular heart disease, lung function impariment that SaO2<90% at room air.
- Ventricular rate below 80/min before any medication
- Permanent pacemaker implanted
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
rate control
Arm Description
Outcomes
Primary Outcome Measures
Change of Maximal Oxygen consumption
acquire the data by Cardiopulmonary exercise test (CPET) with different (low and high) drug dosages for rate control
Secondary Outcome Measures
Full Information
NCT ID
NCT04513509
First Posted
August 9, 2020
Last Updated
August 16, 2020
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04513509
Brief Title
Rate Control in Patients With Atrial Fibrillation
Acronym
RaP-AF
Official Title
The Surrogate Marker of Rate Control in Patients With Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 7, 2020 (Anticipated)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (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
To search for the best marker for the patients in atrial fibrillation with rate control
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Rate Control, Cardiopulmonary Exercise Test
Keywords
Atrial Fibrillation, rate control, cardiopulmonary exercise test
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
rate control
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Atenolol, Bisoprolol, Metoprolol, Nebivolol, Propranolol, Diltiazem, Verapamil, digoxin
Intervention Description
Start with empirical lower dose for 3 months, and then titrate up
Primary Outcome Measure Information:
Title
Change of Maximal Oxygen consumption
Description
acquire the data by Cardiopulmonary exercise test (CPET) with different (low and high) drug dosages for rate control
Time Frame
0, 3, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
20~90 years old
Rate control is preferred after shared decision making
Exclusion Criteria:
cannot cooperate with or complete CPET
has contraindication for CPET, such as uncontrolled heart failure, hypertension, angina, valvular heart disease, lung function impariment that SaO2<90% at room air.
Ventricular rate below 80/min before any medication
Permanent pacemaker implanted
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chih-Chieh Yu, MD.PhD
Phone
+886-2-23123456
Ext
65257
Email
sweetchieh@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chih-Chieh Yu, MD.PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chih-Chieh Yu, MD.PhD.
Phone
886-2-23123456
Ext
65257
Email
sweetchieh@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Rate Control in Patients With Atrial Fibrillation
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