- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02321085
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
March 14, 2019 updated by: Yonsei University
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hui-Nam Pak, MD
- Phone Number: +82-2-2228-8459
- Email: hnpak@yuhs.ac
Study Locations
-
-
-
Seoul, Korea, Republic of, 120-752
- Recruiting
- Severance Cardiovascular Hospital, Yonsei University College of Medicine
-
-
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
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Sinus Rhythm Control group
|
|
Active Comparator: Pulse Rate Control Group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
1 year
|
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)
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Echo cardiography (LV ejection fraction, LV wall thickness, LV mass index, LA dimension, LA appendage velocity, E/E'), EKG, 24 hours Holter recording
|
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
|
Echo cardiography (LV ejection fraction, LV wall thickness, LV mass index, LA dimension, LA appendage velocity, E/E'), EKG, 24 hours Holter recording
|
1 years late
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
November 1, 2014
Primary Completion (Anticipated)
November 1, 2019
Study Completion (Anticipated)
November 1, 2019
Study Registration Dates
First Submitted
November 20, 2014
First Submitted That Met QC Criteria
December 19, 2014
First Posted (Estimate)
December 22, 2014
Study Record Updates
Last Update Posted (Actual)
March 18, 2019
Last Update Submitted That Met QC Criteria
March 14, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2014-0811
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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