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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

Primary Purpose

Heart Failure, Recent Onset Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sinus Rhythm control
Pulse Rate control
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with Heart failure and Atrial fibrillation within 1year (20~80 years old)
  2. LA diameter < 5mm
  3. LVEF 20~49%
  4. patients possible to anticoagulation and anti arrhythmic drug
  5. Expected survival >1yr

Exclusion Criteria:

  1. Impossible to anticoagulation or anti arrhythmic drug
  2. valvular atrial fibrillation ( Mitral valve stenosis, Mitral valve plasty, valve replacement)
  3. LV ejection fraction < 20%
  4. Structural cardiac disease
  5. Catheter ablation history for AF, maze surgery
  6. patient with severe medical disease
  7. Impossible to anticoagulation or anti arrhythmic drug

Sites / Locations

  • Severance Cardiovascular Hospital, Yonsei University College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sinus Rhythm Control group

Pulse Rate Control Group

Arm Description

Start AAD right after evaluating for LA size, EF, LA thrombus, and presence of CAD during anticoagulation Cardioversion after 1 month Rhythm FU schedule (2012 ACC/AHA/ESC guidelines) If AF recur, RFCA

No AAD, just anticoagulation HR control between 60~110bpm (with beta blocker, calcium channel blocker, digoxin) Without the treatment about antiarrhythmia and rhythm control, diffraction of rate control, the subject will be drop out for study.

Outcomes

Primary Outcome Measures

improvement of left ventricular function according to the rhythm control in patient with heart failure and new onset atrial fibrillation
ejection fraction change (echocardiography)
functional capacity according to the rhythm control in patient with heart failure and new onset atrial fibrillation
peak VO2 (cardio pulmonary test ; CPX)

Secondary Outcome Measures

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
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

Full Information

First Posted
November 20, 2014
Last Updated
March 14, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02321085
Brief 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Recent Onset Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sinus Rhythm Control group
Arm Type
Active Comparator
Arm Description
Start AAD right after evaluating for LA size, EF, LA thrombus, and presence of CAD during anticoagulation Cardioversion after 1 month Rhythm FU schedule (2012 ACC/AHA/ESC guidelines) If AF recur, RFCA
Arm Title
Pulse Rate Control Group
Arm Type
Active Comparator
Arm Description
No AAD, just anticoagulation HR control between 60~110bpm (with beta blocker, calcium channel blocker, digoxin) Without the treatment about antiarrhythmia and rhythm control, diffraction of rate control, the subject will be drop out for study.
Intervention Type
Procedure
Intervention Name(s)
Sinus Rhythm control
Intervention Type
Procedure
Intervention Name(s)
Pulse Rate control
Primary Outcome Measure Information:
Title
improvement of left ventricular function according to the rhythm control in patient with heart failure and new onset atrial fibrillation
Description
ejection fraction change (echocardiography)
Time Frame
1 year
Title
functional capacity according to the rhythm control in patient with heart failure and new onset atrial fibrillation
Description
peak VO2 (cardio pulmonary test ; CPX)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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
Description
Echo cardiography (LV ejection fraction, LV wall thickness, LV mass index, LA dimension, LA appendage velocity, E/E'), EKG, 24 hours Holter recording
Time Frame
1 years late
Title
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
Description
Echo cardiography (LV ejection fraction, LV wall thickness, LV mass index, LA dimension, LA appendage velocity, E/E'), EKG, 24 hours Holter recording
Time Frame
1 years late

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui-Nam Pak, MD
Phone
+82-2-2228-8459
Email
hnpak@yuhs.ac
Facility Information:
Facility Name
Severance Cardiovascular Hospital, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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