Rhythm Control Versus Rate Control for New Onset Atrial Fibrillation

NCT05950971 | Terminated DMC

• 1 other identifier: Postoperative NOAF
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation New Onset; Atrial Fibrillation Paroxysmal

Outcome Measures

Primary Outcomes (1)

• Rate of sinus conversion

  Rate of sinus conversion within 48 hours

  within 48 hrs

Secondary Outcomes (2)

• Time to first sinus conversion

  during the same admission period

• Recurrence of atrial fibrillation

  during the same admission period

Study Arms (2)

Rate control strategy group

EXPERIMENTAL

Patients are given diltiazem or esmolol to control heart rate less than 110/min.

Drug: Amiodarone, diltiazem or esmolol

Rhythm control strategy group

EXPERIMENTAL

Patients are given amiodarone for conversion of cardiac rhythm to sinus rhythm.

Drug: Amiodarone, diltiazem or esmolol

Interventions

Amiodarone, diltiazem or esmolol DRUG

Intravenous continuous infusion after loading or bolus dose of amiodarone, diltiazem or esmolol.

Also known as: herben

Rate control strategy group; Rhythm control strategy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Amiodarone; Diltiazem; esmolol

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzazepines

Study Officials

• Hogeol Ryu

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Single blinded randomized controlled trial

Study Record Dates

• First Submitted: December 5, 2021
• First Posted: July 18, 2023
• Study Start: July 1, 2021
• Primary Completion: January 21, 2022
• Study Completion: January 21, 2022
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)