Atrial Fibrillation New OnsetNCT05950971
Rhythm Control Versus Rate Control for New Onset Atrial Fibrillation
A study testing Amiodarone, diltiazem or esmolol in people with Atrial Fibrillation New Onset and Atrial Fibrillation Paroxysmal, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation New Onset, Atrial Fibrillation Paroxysmal
- What is being tested?
- Amiodarone, diltiazem or esmolol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2021to 21 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Amiodarone, diltiazem or esmolol
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amiodarone, diltiazem or esmololDrug
Also called herben
Intravenous continuous infusion after loading or bolus dose of amiodarone, diltiazem or esmolol.
| Study group | Role | What they receive |
|---|---|---|
| Rate control strategy group | Experimental | Patients are given diltiazem or esmolol to control heart rate less than 110/min. Receives: Drug: Amiodarone, diltiazem or esmolol |
| Rhythm control strategy group | Experimental | Patients are given amiodarone for conversion of cardiac rhythm to sinus rhythm. Receives: Drug: Amiodarone, diltiazem or esmolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of sinus conversion
Rate of sinus conversion within 48 hours
Measured: within 48 hrs
Secondary outcomes (2)
Time to first sinus conversion
Time to first sinus conversion
Measured: during the same admission period
Recurrence of atrial fibrillation
Recurrence of atrial fibrillation during the same admission period
Measured: during the same admission period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Jul 2021
- Primary completion21 Jan 2022
- Study completion21 Jan 2022
Why it stopped: Study enrollment too slow, 1 over 6 months
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation New OnsetStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blinded randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Geol Ryu, Seoul National University Hospital
- Investigators
- Hogeol Ryu, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950971
- Sponsor's protocol ID
- Postoperative NOAF
- Status last verified
- Jul 2023
- First submitted
- 5 Dec 2021
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhythm Control Versus Rate Control for New Onset Atrial Fibrillation After Non-cardiac Non-thoracic Surgery
- ClinicalTrials.gov ID
- NCT05950971
- Acronym / sponsor ID
- Postoperative NOAF
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study enrollment too slow, 1 over 6 months
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 21 Jan 2022 (actual)
- Study completion
- 21 Jan 2022 (actual)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adult patients who are diagnosed new onset atrial fibrillation with rapid ventricular response within 7 days after non-cardiac non-thoracic surgery are enrolled.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Rate control strategy group | Experimental | Drug: Amiodarone, diltiazem or esmololPatients are given diltiazem or esmolol to control heart rate less than 110/min. |
| Rhythm control strategy group | Experimental | Drug: Amiodarone, diltiazem or esmololPatients are given amiodarone for conversion of cardiac rhythm to sinus rhythm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amiodarone, diltiazem or esmololAlso: herbenIntravenous continuous infusion after loading or bolus dose of amiodarone, diltiazem or esmolol. | Drug | Rate control strategy group, Rhythm control strategy group |
Primary outcome
Rate of sinus conversion
Time frame: within 48 hrs
Rate of sinus conversion within 48 hours
2 secondary outcomes
Time to first sinus conversion
Time frame: during the same admission period
Recurrence of atrial fibrillation
Time frame: during the same admission period
Results and safety
The study was stopped early (reason given: Study enrollment too slow, 1 over 6 months). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hogeol Ryu principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amiodarone, diltiazem or esmolol in people with Atrial Fibrillation New Onset and Atrial Fibrillation Paroxysmal, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study enrollment too slow, 1 over 6 months). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of sinus conversion (time frame: within 48 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.