Rate Control in Patients With Atrial Fibrillation (RaP-AF)

August 16, 2020 updated by: National Taiwan University Hospital

The Surrogate Marker of Rate Control in Patients With Atrial Fibrillation

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rate control
Drug: Atenolol, Bisoprolol, Metoprolol, Nebivolol, Propranolol, Diltiazem, Verapamil, digoxin
Start with empirical lower dose for 3 months, and then titrate up

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 7, 2020

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

August 9, 2020

First Submitted That Met QC Criteria

August 12, 2020

First Posted (Actual)

August 14, 2020

Study Record Updates

Last Update Posted (Actual)

August 18, 2020

Last Update Submitted That Met QC Criteria

August 16, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202006205RIND

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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