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Rhythm Control Versus Rate Control for New Onset Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05950971
Recruitment Status : Terminated (Study enrollment too slow, 1 over 6 months)
First Posted : July 18, 2023
Last Update Posted : July 18, 2023
Sponsor:
Information provided by (Responsible Party):
Ho Geol Ryu, Seoul National University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation New Onset Atrial Fibrillation Paroxysmal Drug: Amiodarone, diltiazem or esmolol Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single blinded randomized controlled trial
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Rhythm Control Versus Rate Control for New Onset Atrial Fibrillation After Non-cardiac Non-thoracic Surgery
Actual Study Start Date : July 1, 2021
Actual Primary Completion Date : January 21, 2022
Actual Study Completion Date : January 21, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: herben


Outcome Measures
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Primary Outcome Measures :
  1. Rate of sinus conversion [ Time Frame: within 48 hrs ]
    Rate of sinus conversion within 48 hours


Secondary Outcome Measures :
  1. Time to first sinus conversion [ Time Frame: during the same admission period ]
    Time to first sinus conversion

  2. Recurrence of atrial fibrillation [ Time Frame: during the same admission period ]
    Recurrence of atrial fibrillation during the same admission period


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05950971


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Hogeol Ryu Seoul National University Hospital
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Ho Geol Ryu, Associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT05950971    
Other Study ID Numbers: Postoperative NOAF
First Posted: July 18, 2023    Key Record Dates
Last Update Posted: July 18, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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