Atrial FibrillationAF-CPXNCT01943981
Exercise Performance in Patients With Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Incheon St.Mary's Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to Feb 2015
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with atrial fibrillation and preserved left ventricular systolic function
Who may be able to join
- Nonvalvular chronic atrial fibrillation
- Left ventricular ejection fraction >40%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Incheon St.Mary's Hospital
Incheon, 403-720
Kim, 82322805163, mjkim@catholic.ac.kr
Kim, heart3162@hanmail.net
About this study
Official title: 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.
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Optimal/inappropriate exercise response | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise response patterns of heart rate and oxygen uptake
Measured: At baseline
Secondary outcomes (1)
Composite cardiovascular events (all death, admission of heart failure, stroke/thromboembolism)
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Incheon St.Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mi-Jeong Kim, Incheon St.Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943981
- Sponsor's protocol ID
- OC13OISI0099
- Acronym
- AF-CPX
- Status last verified
- Sep 2013
- First submitted
- 12 Sep 2013
- Last updated
- 17 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Performance in Patients With Atrial Fibrillation: Usefulness of Cardiopulmonary Exercise Test
- ClinicalTrials.gov ID
- NCT01943981
- Acronym / sponsor ID
- AF-CPX / OC13OISI0099
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Incheon St.Mary's HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Feb 2015 (estimated)
- First posted
- 17 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optimal/inappropriate exercise response | – | – |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with atrial fibrillation and preserved left ventricular systolic function
Key inclusion criteria (2 listed)
- Nonvalvular chronic atrial fibrillation
- Left ventricular ejection fraction >40%
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Exercise response patterns of heart rate and oxygen uptake
Time frame: At baseline
1 secondary outcome
Composite cardiovascular events (all death, admission of heart failure, stroke/thromboembolism)
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Incheon St.Mary's Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise response patterns of heart rate and oxygen uptake (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2013.