Heart FailureNCT02321085
The Comparison With Clinical Impacts on Functional Capacity and Symptom Improvement According to the Rhythm Control in Patients With Heart Failure and Recent Onset Atrial Fibrillation
A study of Heart Failure and Recent Onset Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
Trial summary
Prospective randomized (rhythm control or rate control in heart failure patients with new onset atrial fibrillation) Objective of study 1. To analyze long term outcome of patients with heart failure with new onset atrial fibrillation according to the rhythm control 2. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heart Failure, Recent Onset Atrial Fibrillation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2014to Nov 2019
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Heart failure and Atrial fibrillation within 1year (20~80 years old)
- LA diameter < 5mm
- LVEF 20~49%
- patients possible to anticoagulation and anti arrhythmic drug
- Expected survival >1yr
Who cannot join
- Impossible to anticoagulation or anti arrhythmic drug
- valvular atrial fibrillation ( Mitral valve stenosis, Mitral valve plasty, valve replacement)
- LV ejection fraction < 20%
- Structural cardiac disease
- Catheter ablation history for AF, maze surgery
- patient with severe medical disease
- Impossible to anticoagulation or anti arrhythmic drug
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, 120-752
About this study
Prospective randomized (rhythm control or rate control in heart failure patients with new onset atrial fibrillation) Objective of study 1. To analyze long term outcome of patients with heart failure with new onset atrial fibrillation according to the rhythm control 2. To analyze remodeling of atrium and ventricle by the new onset AF in heart failure patients 3. To analyze the change of LV function and functional capacity according to the rhythm in patients with HF and new onset AF
- Conditions
- Heart Failure, Recent Onset Atrial Fibrillation
- Being tested
- Sinus Rhythm control, Pulse Rate control
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinus Rhythm controlProcedure or surgery
Pulse Rate controlProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Sinus Rhythm Control group | Active comparator | 1. Start AAD right after evaluating for LA size, EF, LA thrombus, and presence of CAD during anticoagulation
2. Cardioversion after 1 month
3. Rhythm FU schedule (2012 ACC/AHA/ESC guidelines)
4. If AF recur, RFCA Receives: Procedure: Sinus Rhythm control |
| Pulse Rate Control Group | Active comparator | 1. No AAD, just anticoagulation
2. HR control between 60~110bpm (with beta blocker, calcium channel blocker, digoxin)
3. Without the treatment about antiarrhythmia and rhythm control, diffraction of rate control, the subject will be drop out for study. Receives: Procedure: Pulse Rate control |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of left ventricular function according to the rhythm control in patient with heart failure and new onset atrial fibrillation
ejection fraction change (echocardiography)
Measured: 1 year
functional capacity according to the rhythm control in patient with heart failure and new onset atrial fibrillation
peak VO2 (cardio pulmonary test ; CPX)
Measured: 1 year
Secondary outcomes (2)
remodeling of atrium by the new onset AF in heart failure patients The change of LV function and functional capacity according to the rhythm in patients with HF and new onset AF
Echo cardiography (LV ejection fraction, LV wall thickness, LV mass index, LA dimension, LA appendage velocity, E/E'), EKG, 24 hours Holter recording
Measured: 1 years late
remodeling of ventricle by the new onset AF in heart failure patients The change of LV function and functional capacity according to the rhythm in patients with HF and new onset AF
Echo cardiography (LV ejection fraction, LV wall thickness, LV mass index, LA dimension, LA appendage velocity, E/E'), EKG, 24 hours Holter recording
Measured: 1 years late
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321085
- Sponsor's protocol ID
- 4-2014-0811
- Status last verified
- Mar 2019
- First submitted
- 20 Nov 2014
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison With Clinical Impacts on Functional Capacity and Symptom Improvement According to the Rhythm Control in Patients With Heart Failure and Recent Onset Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02321085
- Acronym / sponsor ID
- 4-2014-0811
- Conditions
- Heart Failure, Recent Onset Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 22 Dec 2014 (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.
Prospective randomized (rhythm control or rate control in heart failure patients with new onset atrial fibrillation) Objective of study 1. To analyze long term outcome of patients with heart failure with new onset atrial fibrillation according to the rhythm control 2. To analyze remodeling of atrium and ventricle by the new onset AF in heart failure patients 3. To analyze the change of LV function and functional capacity according to the rhythm in patients with HF and new onset AF
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sinus Rhythm Control group | Active comparator | Procedure: Sinus Rhythm control1. Start AAD right after evaluating for LA size, EF, LA thrombus, and presence of CAD during anticoagulation 2. Cardioversion after 1 month 3. Rhythm FU schedule (2012 ACC/AHA/ESC guidelines) 4. If AF recur, RFCA |
| Pulse Rate Control Group | Active comparator | Procedure: Pulse Rate control1. No AAD, just anticoagulation 2. HR control between 60~110bpm (with beta blocker, calcium channel blocker, digoxin) 3. Without the treatment about antiarrhythmia and rhythm control, diffraction of rate control, the subject will be drop out for study. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with Heart failure and Atrial fibrillation within 1year (20~80 years old)
- LA diameter < 5mm
- LVEF 20~49%
- patients possible to anticoagulation and anti arrhythmic drug
- Expected survival >1yr
Key exclusion criteria (7 listed)
- Impossible to anticoagulation or anti arrhythmic drug
- valvular atrial fibrillation ( Mitral valve stenosis, Mitral valve plasty, valve replacement)
- LV ejection fraction < 20%
- Structural cardiac disease
- Catheter ablation history for AF, maze surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sinus Rhythm control | Procedure or surgery | Sinus Rhythm Control group |
| Pulse Rate control | Procedure or surgery | Pulse Rate Control Group |
Primary outcome
improvement of left ventricular function according to the rhythm control in patient with heart failure and new onset atrial fibrillation
Time frame: 1 year
ejection fraction change (echocardiography)
functional capacity according to the rhythm control in patient with heart failure and new onset atrial fibrillation
Time frame: 1 year
peak VO2 (cardio pulmonary test ; CPX)
2 secondary outcomes
remodeling of atrium by the new onset AF in heart failure patients The change of LV function and functional capacity according to the rhythm in patients with HF and new onset AF
Time frame: 1 years late
remodeling of ventricle by the new onset AF in heart failure patients The change of LV function and functional capacity according to the rhythm in patients with HF and new onset AF
Time frame: 1 years late
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
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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?
A study of Heart Failure and Recent Onset Atrial Fibrillation, run by Yonsei University 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 5 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 18 Mar 2019. 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?
Contact Hui-Nam Pak, MD (+82-2-2228-8459, hnpak@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of left ventricular function according to the rhythm control in patient with heart failure and new onset atrial fibrillation (time frame: 1 year). The study lists 2 primary outcomes in all. 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 18 Mar 2019.