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

Not Applicable

• Conditions: Heart Failure; Recent Onset Atrial Fibrillation
• Interventions: Procedure: Sinus Rhythm control; Procedure: Pulse Rate control

• Registration Number: NCT02321085
• Lead Sponsor: Yonsei University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-20
• Study First Submitted QC: 2014-12-19
• Study First Posted: 2014-12-22
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-14
• Last Update Posted: 2019-03-18
• Primary Completion: 2019-11
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sinus Rhythm Control group	Sinus Rhythm control	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
Pulse Rate Control Group	Pulse Rate control	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.

Primary Outcome Measures

Name	Time	Method
improvement of left ventricular function according to the rhythm control in patient with heart failure and new onset atrial fibrillation	1 year	ejection fraction change (echocardiography)
functional capacity according to the rhythm control in patient with heart failure and new onset atrial fibrillation	1 year	peak VO2 (cardio pulmonary test ; CPX)

Secondary Outcome Measures

Name	Time	Method
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	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
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	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

Trial Locations

Locations (1)

Severance Cardiovascular Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of