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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01943981
Other study ID # OC13OISI0099
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 12, 2013
Last updated September 12, 2013
Start date September 2013

Study information

Verified date September 2013
Source Incheon St.Mary's Hospital
Contact n/a
Is FDA regulated No
Health authority Korea (the Republic of): the Clinical Research Cordinating Center (CRCC) of the Catholic University Center
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 80 Years
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Incheon St.Mary's Hospital Incheon

Sponsors (1)

Lead Sponsor Collaborator
Incheon St.Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Exercise response patterns of heart rate and oxygen uptake At baseline No
Secondary Composite cardiovascular events (all death, admission of heart failure, stroke/thromboembolism) Up to 2 years No
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