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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02321085
Enrollment
150
Registered
2014-12-22
Start date
2014-11-30
Completion date
2019-11-30
Last updated
2019-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Recent Onset Atrial Fibrillation

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

Interventions

PROCEDURESinus Rhythm control
PROCEDUREPulse Rate control

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
improvement of left ventricular function according to the rhythm control in patient with heart failure and new onset atrial fibrillation1 yearejection fraction change (echocardiography)
functional capacity according to the rhythm control in patient with heart failure and new onset atrial fibrillation1 yearpeak VO2 (cardio pulmonary test ; CPX)

Secondary

MeasureTime frameDescription
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 AF1 years lateEcho 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 AF1 years lateEcho cardiography (LV ejection fraction, LV wall thickness, LV mass index, LA dimension, LA appendage velocity, E/E'), EKG, 24 hours Holter recording

Countries

South Korea

Contacts

Primary ContactHui-Nam Pak, MD
hnpak@yuhs.ac+82-2-2228-8459

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026