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

Yonsei University

Status: Unknown

Conditions: Heart Failure; Recent Onset Atrial Fibrillation

Treatments: Procedure: Pulse Rate control; Procedure: Sinus Rhythm control

Study type: Interventional

Funder types: Other

Identifiers

NCT02321085

4-2014-0811

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Sinus Rhythm Control group

Active Comparator group

Description:

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

Treatment:

Procedure: Sinus Rhythm control

Pulse Rate Control Group

Active Comparator group

Description:

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.

Treatment:

Procedure: Pulse Rate control