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

Heart Failure Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02321085
• Other study ID #: 4-2014-0811
• Status: Recruiting
• Phase: N/A
• Start date: November 2014
• Est. completion date: November 2019

Study information

• Verified date: March 2019
• Source: Yonsei University
• Contact: Hui-Nam Pak, MD
• Phone: +82-2-2228-8459
• Email: hnpak[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure
• Recent Onset Atrial Fibrillation

Intervention

Procedure:
• Sinus Rhythm control

• Pulse Rate control

Locations

Country	Name	City	State
Korea, Republic of	Severance Cardiovascular Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement of left ventricular function according to the rhythm control in patient with heart failure and new onset atrial fibrillation	ejection fraction change (echocardiography)	1 year
Primary	functional capacity according to the rhythm control in patient with heart failure and new onset atrial fibrillation	peak VO2 (cardio pulmonary test ; CPX)	1 year
Secondary	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	1 years late
Secondary	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	1 years late