Exercise Performance in Patients With Atrial Fibrillation (AF-CPX)

September 12, 2013 updated by: Mi-Jeong Kim, Incheon St.Mary's Hospital

Exercise Performance in Patients With Atrial Fibrillation: Usefulness of Cardiopulmonary Exercise Test

Heart failure and stroke are the two major complication of atrial fibrillation. Current treatment for atrial fibrillation is so focused to stroke prevention, but the risk assessment for heart failure is less highlighted. The most of patients with atrial fibrillation have cardiac functional limitation of variable degree. We hypothesize that the exercise test would reveal the subclinical cardiac dysfunction, and might be helpful to classify the patients with atrial fibrillation according to their exercise capacity real cardiac function.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

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

Study Locations

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

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with atrial fibrillation and preserved left ventricular systolic function

Description

Inclusion Criteria:

  • Nonvalvular chronic atrial fibrillation
  • Left ventricular ejection fraction >40%

Exclusion Criteria:

  • Acute decompensated heart failure within 30 days
  • unstable hemodynamic status
  • Significant coronary artery disease
  • Any condition interfering sufficient exercise
  • Valvular stenosis or regurgitation of moderate or severe degree
  • Obstructive or restrictive lung disease of moderate or severe degree
  • Active malignancy

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

Cohorts and Interventions

Group / Cohort
Optimal/inappropriate exercise response

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Exercise response patterns of heart rate and oxygen uptake
Time Frame: At baseline
At baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Composite cardiovascular events (all death, admission of heart failure, stroke/thromboembolism)
Time Frame: Up to 2 years
Up to 2 years

Collaborators and Investigators

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

Sponsor

Incheon St.Mary's 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

September 1, 2013

Primary Completion (Anticipated)

February 1, 2015

Study Registration Dates

First Submitted

September 12, 2013

First Submitted That Met QC Criteria

September 12, 2013

First Posted (Estimate)

September 17, 2013

Study Record Updates

Last Update Posted (Estimate)

September 17, 2013

Last Update Submitted That Met QC Criteria

September 12, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OC13OISI0099

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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