Atrial FibrillationPhase 4FAACNCT04223739
Comparison of Two Strategies for the Management of Atrial Fibrillation After Cardiac Surgery
A Phase 4 study testing Landiolol and Amiodarone in people with Atrial Fibrillation and Cardiac Surgery, run by University Hospital, Caen at 1 site in France.
Trial summary
Postoperative atrial fibrillation is a common complication after cardiac surgery with a rate of 30%. However, management of postoperative atrial fibrillation is controversial. Two strategies are recommended : heart rate control using a betablocker or rhythm control with amiodarone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Cardiac Surgery
- What is being tested?
- Landiolol and Amiodarone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2019to 1 Jun 2022
- Phase
- Phase 4
- 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
- Adult patients hospitalized in the cardiac ICU after having undergone cardiac surgery (CABG, aortic valve or ascending aortic root replacement or a combination of both)
- New onset of atrial fibrillation lasting more than 30 minutes in the postoperative period after cardiac surgery
- French speaking patients
- Written consent
- Patients with social security insurance
Who cannot join
- Hemodynamic instability requiring electrical cardioversion of atrial fibrillation
- Sepsis
- Bradyarrythmia (< 90/min)
- Patients requiring inotropes in the postoperative period
- Patient with pre-existing atrial fibrillation
- Patient with anticoagulant therapy before surgery
Show all 12Show fewer
- Contraindication to amiodarone or beta-blockers
- Urgent surgery (< 24h), ventricular assist device, heart transplant, TAVR, mechanical valve, mitral or tricuspid valve replacement.
- No written consent
- Pregnant women,
- Underaged patients (<18 years old)
- Patients not able to give consent (curators, patients deprived of public rights)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Caen University Hospital
Caen, Calvados, 14000
Edouard Caspersen, MD, +33 02 31 06 47 36, caspersen-e@chu-caen.fr
Edouard Caspersen, MD
About this study
Official title: Comparison of Two Strategies for the Management of Atrial Fibrillation After Cardiac Surgery : a Randomized Multicenter Clinical Trial
Postoperative atrial fibrillation is a common complication after cardiac surgery with a rate of 30%. However, management of postoperative atrial fibrillation is controversial. Two strategies are recommended : heart rate control using a betablocker or rhythm control with amiodarone.
Landiolol is a new-generation beta-blocker with a short half-life, which was approved by the Haute Autorité de Santé to be used in perioperative supra-ventricular tachycardias.
Read more
Only one study compared landiolol to amiodarone in the perioperative setting, with a better hemodynamic tolerance and a higher rate of conversion to sinus rhythm with landiolol. However this was a single-center and retrospective study.
The aim of our multicenter randomized study is to compare the effectiveness of landiolol in reducing atrial fibrillation to sinus rhythm compared to amiodarone in the postoperative period after cardiac surgery.
Read the detailed description
Randomized clinical study comparing landiolol and amiodarone for treatment of atrial fibrillation following cardiac surgery
- Conditions
- Atrial Fibrillation, Cardiac Surgery
- Being tested
- Landiolol, Amiodarone
- Keywords
- Cardiac Surgery, Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LandiololDrug
Also called Rapibloc
Landiolol infusion with incremental doses (range from 2,5µg/kg/min to 80 µg/kg/min) with go of heart rate < 90 bpm. Doses are modified every 10 minutes if necessary.
Once heart rate goal is obtained, switch to an oral dose of Bisoprolol.
AmiodaroneDrug
Also called Cordarone
Amiodarone loading dose of 5-7 mg/kg in 1 hour followed by an infusion of 1 g/day until conversion to sinus rhythm. Once sinus rhythm is obtained, switch to an oral dose of 200mg/day
| Study group | Role | What they receive |
|---|---|---|
| Landiolol | Active comparator | Landiolol infusion starting at 2.5 µg/kg/min and titrating up to 80µg/kg/min with a heart rate goal of under 90 bpm. Receives: Drug: Landiolol |
| Amiodarone | Active comparator | Amiodarone bolus of 5-7 mg/kg in 1 hour, followed by an infusion of 1g/day until conversion to sinus rhythm. Receives: Drug: Amiodarone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients in sinus rhythm 48 hours after the onset of atrial fibrillation immediate postoperative period after cardiac surgery
Percentage of patients in sinus rhythm 48 hours after the onset of atrial fibrillation immediate postoperative period after cardiac surgery
Measured: Day 2 after onset of atrial fibrillation
Secondary outcomes (6)
Haemodynamic side effects (hypotension, bradycardia)
Haemodynamic side effects (hypotension, bradycardia)
Measured: Day 8 after onset of atrial fibrillation and through hospital discharge, an average of 14 days
Length of hospital stay
Length of stay in the hospital from randomisation to hospital discharge
Measured: Day 8 after onset of atrial fibrillation and through hospital discharge, an average of 14 days
Rate of thrombo-embolic events
Rate of stroke or ischemic embolism
Measured: 2 months postsugery and 1 year postsurgery
Quality of life evaluated by the EQ 5D 3L questionnaire
Quality of life as evaluated by the EQ 5D 3L questionnaire
Measured: 2 months postsurgery and 1 year postsurgery
Rate of atrial fibrillation recurrence
Percentage of patients having a recurrence of atrial fibrillation after the initial conversion to sinus rythm in the postoperative period
Measured: 2 months postsurgery and 1 year postsurgery
Severe hemorrhagic complications due to anticoagulant therapy, as defined by the Haute Autorité de Santé
Hemorrhagic complications requiring surgery or interventional radiology Hemorrhagic complications responsible of hemodynamic instability (Systolic Arterial Pressure < 90 mmHg, or drop of more than 40 mmHg or Mean Arterial Pressure < 65 mmHg or signs of shock) Life threatening hemorrhagic complications (intracerebral, intramedullar or intraocular hemorrhage, hemothorax, abdominal hemorrhage, deep muscular hemorrhage
Measured: 2 months postsurgery and 1 year postsurgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start13 Dec 2019
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edouard Caspersen, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223739
- Sponsor's protocol ID
- 2019-A00763-54
- Acronym
- FAAC
- Status last verified
- Jan 2020
- First submitted
- 13 Dec 2019
- Last updated
- 10 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Caspersen E, Guinot PG, Rozec B, Oilleau JF, Fellahi JL, Gaudard P, Lorne E, Mahjoub Y, Besnier E, Moussa MD, Mongardon N, Hanouz JL, Briant AR, Paul LPS, Tomadesso C, Parienti JJ, Descamps R, Denisenko A, Fischer MO; ARCOTHOVA Group. Comparison of landiolol and amiodarone for the treatment of new-onset atrial fibrillation after cardiac surgery (FAAC) trial: study protocol for a randomized controlled trial. Trials. 2023 May 25;24(1):353. doi: 10.1186/s13063-023-07353-6.
PubMed 37226174
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Strategies for the Management of Atrial Fibrillation After Cardiac Surgery : a Randomized Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT04223739
- Acronym / sponsor ID
- FAAC / 2019-A00763-54
- Conditions
- Atrial Fibrillation, Cardiac Surgery
- Keywords
- Cardiac Surgery, Atrial Fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 10 Jan 2020 (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.
Postoperative atrial fibrillation is a common complication after cardiac surgery with a rate of 30%. However, management of postoperative atrial fibrillation is controversial. Two strategies are recommended : heart rate control using a betablocker or rhythm control with amiodarone.
Landiolol is a new-generation beta-blocker with a short half-life, which was approved by the Haute Autorité de Santé to be used in perioperative supra-ventricular tachycardias.
Only one study compared landiolol to amiodarone in the perioperative setting, with a better hemodynamic tolerance and a higher rate of conversion to sinus rhythm with landiolol. However this was a single-center and retrospective study.
The aim of our multicenter randomized study is to compare the effectiveness of landiolol in reducing atrial fibrillation to sinus rhythm compared to amiodarone in the postoperative period after cardiac surgery.
Detailed description
Randomized clinical study comparing landiolol and amiodarone for treatment of atrial fibrillation following cardiac surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Landiolol | Active comparator | Drug: LandiololLandiolol infusion starting at 2.5 µg/kg/min and titrating up to 80µg/kg/min with a heart rate goal of under 90 bpm. |
| Amiodarone | Active comparator | Drug: AmiodaroneAmiodarone bolus of 5-7 mg/kg in 1 hour, followed by an infusion of 1g/day until conversion 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)
- Adult patients hospitalized in the cardiac ICU after having undergone cardiac surgery (CABG, aortic valve or ascending aortic root replacement or a combination of both)
- New onset of atrial fibrillation lasting more than 30 minutes in the postoperative period after cardiac surgery
- French speaking patients
- Written consent
- Patients with social security insurance
Key exclusion criteria (12 listed)
- Hemodynamic instability requiring electrical cardioversion of atrial fibrillation
- Sepsis
- Bradyarrythmia (< 90/min)
- Patients requiring inotropes in the postoperative period
- Patient with pre-existing atrial fibrillation
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 |
|---|---|---|
| LandiololAlso: RapiblocLandiolol infusion with incremental doses (range from 2,5µg/kg/min to 80 µg/kg/min) with go of heart rate < 90 bpm. Doses are modified every 10 minutes if necessary. Once heart rate goal is obtained, switch to an oral dose of Bisoprolol. | Drug | Landiolol |
| AmiodaroneAlso: CordaroneAmiodarone loading dose of 5-7 mg/kg in 1 hour followed by an infusion of 1 g/day until conversion to sinus rhythm. Once sinus rhythm is obtained, switch to an oral dose of 200mg/day | Drug | Amiodarone |
Primary outcome
Percentage of patients in sinus rhythm 48 hours after the onset of atrial fibrillation immediate postoperative period after cardiac surgery
Time frame: Day 2 after onset of atrial fibrillation
Percentage of patients in sinus rhythm 48 hours after the onset of atrial fibrillation immediate postoperative period after cardiac surgery
6 secondary outcomes
Haemodynamic side effects (hypotension, bradycardia)
Time frame: Day 8 after onset of atrial fibrillation and through hospital discharge, an average of 14 days
Length of hospital stay
Time frame: Day 8 after onset of atrial fibrillation and through hospital discharge, an average of 14 days
Rate of thrombo-embolic events
Time frame: 2 months postsugery and 1 year postsurgery
Quality of life evaluated by the EQ 5D 3L questionnaire
Time frame: 2 months postsurgery and 1 year postsurgery
Rate of atrial fibrillation recurrence
Time frame: 2 months postsurgery and 1 year postsurgery
Severe hemorrhagic complications due to anticoagulant therapy, as defined by the Haute Autorité de Santé
Time frame: 2 months postsurgery and 1 year postsurgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Derived from this study: PubMed 37226174Caspersen E, Guinot PG, Rozec B, Oilleau JF, Fellahi JL, Gaudard P, Lorne E, Mahjoub Y, Besnier E, Moussa MD, Mongardon N, Hanouz JL, Briant AR, Paul LPS, Tomadesso C, Parienti JJ, Descamps R, Denisenko A, Fischer MO; ARCOTHOVA Group. Comparison of landiolol and amiodarone for the treatment of new-onset atrial fibrillation after cardiac surgery (FAAC) trial: study protocol for a randomized controlled trial. Trials. 2023 May 25;24(1):353. doi: 10.1186/s13063-023-07353-6.
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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.
Edouard Caspersen, MD principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Landiolol and Amiodarone in people with Atrial Fibrillation and Cardiac Surgery, run by University Hospital, Caen at 1 site in France.
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 12 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: status not confirmed, as of the sponsor's last update on 10 Jan 2020. 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 France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edouard Caspersen, MD (+33 02 31 06 47 36, caspersen-e@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients in sinus rhythm 48 hours after the onset of atrial fibrillation immediate postoperative period after cardiac surgery (time frame: Day 2 after onset of atrial fibrillation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04223739, which also lists 1 linked publication.
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 10 Jan 2020.