NCT01943981

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 17, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Last Updated

September 17, 2013

Status Verified

September 1, 2013

Enrollment Period

1.4 years

First QC Date

September 12, 2013

Last Update Submit

September 12, 2013

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Exercise response patterns of heart rate and oxygen uptake

    At baseline

Secondary Outcomes (1)

  • Composite cardiovascular events (all death, admission of heart failure, stroke/thromboembolism)

    Up to 2 years

Study Arms (1)

Optimal/inappropriate exercise response

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with atrial fibrillation and preserved left ventricular systolic function

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Incheon St.Mary's Hospital

Incheon, 403-720, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

September 12, 2013

First Posted

September 17, 2013

Study Start

September 1, 2013

Primary Completion

February 1, 2015

Last Updated

September 17, 2013

Record last verified: 2013-09

Locations

KR(1)