Rhythm Control Versus Rate Control for New Onset Atrial Fibrillation

Rhythm Control Versus Rate Control for New Onset Atrial Fibrillation After Non-cardiac Non-thoracic Surgery

Adult patients who are diagnosed new onset atrial fibrillation with rapid ventricular response within 7 days after non-cardiac non-thoracic surgery are enrolled.

Study Overview

• Status: Terminated
• Conditions: Atrial Fibrillation New Onset; Atrial Fibrillation Paroxysmal
• Intervention / Treatment: Drug: Amiodarone, diltiazem or esmolol

Detailed Description

After randomization, they are allocated to rhythm control strategy group or rate control strategy group. In rhythm control strategy group, patients are given amiodarone primarily for the purpose of sinus conversion of cardiac rhythm. In rate control strategy group, patients are given diltiazem or esmolol for the purpose of rate control. the rate of sinus conversion within 48 hours after treatment are compared.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Older than 18 years
• Newly diagnosed atrial fibrillation or flutter
• Patients with atrial fibrillation or flutter that occurred within 7 days after non-cardiac non-thoracic surgery
• Atrial fibrillation or flutter with rapid ventricular response(HR ≥110/min)
• Patients without hemodynamic instability (MBP≥65mmHg with norepinephrine continuous infusion less than 5mcg/min or without vasopressor support)

Exclusion Criteria:

• Atrial fibrillation or flutter prolonged more than 48 hours without anticoagulation
• Patients who have decreased cardiac function or heart failure (EF <40%)
• Patients who have cardiac conduction disorder, QT prolongation(QTc ≥500ms)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rate control strategy group; Patients are given diltiazem or esmolol to control heart rate less than 110/min.	Drug: Amiodarone, diltiazem or esmolol; Intravenous continuous infusion after loading or bolus dose of amiodarone, diltiazem or esmolol.; Other Names: herben
Experimental: Rhythm control strategy group; Patients are given amiodarone for conversion of cardiac rhythm to sinus rhythm.	Drug: Amiodarone, diltiazem or esmolol; Intravenous continuous infusion after loading or bolus dose of amiodarone, diltiazem or esmolol.; Other Names: herben

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of sinus conversion	Rate of sinus conversion within 48 hours	within 48 hrs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first sinus conversion	Time to first sinus conversion	during the same admission period
Recurrence of atrial fibrillation	Recurrence of atrial fibrillation during the same admission period	during the same admission period

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Hogeol Ryu, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): January 21, 2022
• Study Completion (Actual): January 21, 2022

Study Registration Dates

• First Submitted: December 5, 2021
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Enzyme Inhibitors; Membrane Transport Modulators; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Sodium Channel Blockers; Cytochrome P-450 CYP2D6 Inhibitors; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Adrenergic beta-1 Receptor Antagonists; Potassium Channel Blockers; Esmolol; Diltiazem; Amiodarone
• Other Study ID Numbers: Postoperative NOAF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No