Atrial FibrillationPhase 3LANDI-POAFNCT05084118
Landiolol for Prevention of Postoperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
A Phase 3 study testing Landiolol HCl in people with Atrial Fibrillation and Postoperative Complications, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Postoperative atrial fibrillation (POAF) is the most common arrhythmia after cardiac surgery with incidences ranging from 20% to 40% with the consequence of increasing mortality, morbidity, and hospital length of stay, as well as increasing the costs to the health care system. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Postoperative Complications
- What is being tested?
- Landiolol HCl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 1 siteAustria
- Study dates
- 21 Oct 2021to 1 Jun 2024
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female patients ≥ 18 years old
- Written informed consent from patient
- Patients are in sinus rhythm
- Oral Betablocker in the patients long-term medication
- One of the following cardiac surgical procedures which is planned on cardiopulmonary bypass (CPB):
- Single valve surgery
Show all 12Show fewer
- Single or multiple CABG procedures
- Single valve surgery in combination with one or multiple coronary artery bypass grafts (CABGs)
- Multiple valve surgery in combination with or without CABG
- Single or multiple valve surgery in combination with ascending aorta procedure with or without additional CABG
- Re-surgery of aortic valve, mitral valve, aortic arch or ascending aorta with or without CABG
- Cardiac surgery is performed electively
Who cannot join
- Bodyweight > 101kg and/or BMI ≥ 40
- Cardiac surgery is planned as minimally invasive procedure (e.g., without thoracotomy or with lateral incision, minimal thoracotomy) or planned as off-pump surgery
- Planned maze procedure, radiofrequency ablation, pulmonary vein ablation, resection of the atrial appendix or atrial resections during the surgery
- Sinus bradycardia (resting heart rate < 50/min) at screening and before start of IMP treatment
- Second- or third-degree atrioventricular block at screening and before start of IMP treatment
- Clinical hypothyroidism or hyperthyroidism at screening
Show all 30Show fewer
- History of ventricular arrhythmia
- Permanent atrial fibrillation or atrial fibrillation at time of screening and IMP administration
- Emergency cardiac surgery
- Requiring inotropic, vasopressor or requiring ventilatory support at time of screening
- Circulatory shock requiring mechanical circulatory support before initiation of study medication
- Distributive shock (cardiac index>2.2 L/min with norepinephrine dose > 0.3 µg/kg/min to reach mean arterial pressure > 65mmHg) before initiation of study medication
- More than 5 units of RBC necessary to maintain a haemoglobin level >8mg/dl at the end of surgery
- Prior cardiac surgery within the past 6 months
- History of heart transplantation or planned heart transplantation
- Any other disease or condition that is likely to interfere with the evaluation of the study drug, outcome assessment or satisfactory conduct of the study:
- Active infective endocarditis
- Stroke or transient ischemic attack (TIA) within the last 6 months
- Concomitant disease with a life expectancy of less than 6 months
- Cardiopulmonary resuscitation within the last 4 weeks
- Patients requiring renal replacement therapy
- Active infection on current systemic antibiotics and/ or temperature greater than 38°C at time of screening and before start of surgery
- Haemoglobin < 5 mmol/l (< 8.06 g/dl)
- Any systemic anti-cancer therapy within past 3 months
- Patients with known hypersensitivity to any constituent of the IMP
- General exclusion criteria:
- Pregnant (in women of childbearing potential a urine or blood pregnancy test has to be performed) or breast-feeding women. Women with childbearing potential (defined as within two years of their last menstruation) not willing to practice appropriate contraceptive measures (e.g., implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy, abstinence) while participating in the trial
- Participation in any interventional clinical trial within the last one-month prior randomization in this clinicaltrial (screening failures can be rescreened, if appropriate)
- Alcohol, drug, or medication abuse
- Employee at the study site, spouse/partner or relative of any study staff (e.g., investigator, subinvestigators, or study nurse) or relationship to the sponsor
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
University Hospital Vienna
Vienna, 1090
Andreas Binder, MD, andreas.binder@meduniwien.ac.at
Barbara Steinlechner, Prof., barbara.steinlechner@meduniwien.ac.at
About this study
Official title: A Prospective, Randomized, Double- Blind, Placebo- Controlled Study to Evaluate the Efficacy of Landiolol Hydrochloride for Prevention of Atrial Fibrillation in Patients Undergoing Cardiac Surgery
Postoperative atrial fibrillation (POAF) is the most common arrhythmia after cardiac surgery with incidences ranging from 20% to 40% with the consequence of increasing mortality, morbidity, and hospital length of stay, as well as increasing the costs to the health care system. To prevent POAF the use of beta-blockers is suggested by the EACTA and ESC guidelines. Despite the prophylactic use, the discontinuation of beta-blockers in the perioperative period is a known risk factor that contributes to the occurrence of POAF. Due to the short half time and the highly beta-1-selective properties of Landiolol, it could be possible to initiate a betablocker for prevention in the immediate postoperative setting, without adverse effects like hypotension or severe bradycardia as seen with other betablockers like Metoprolol or even sometimes Esmolol.
Landiolol is already approved for the treatment of atrial tachycardias but is not yet approved for the use of prevention of POAF. In multiple previous studies the preventive potential of Landiolol in cardiac surgery could be proven in japanese study populations, with limitations due to limited sample sizes. In these trials the use of low-dose Landiolol effectively reduced the incidence of POAF without significant differences of increased side effects or in the hemodynamic stability compared to the placebo or standard of care groups.
The primary objective of this prospective, double-blind, randomized, placebo-controlled phase III trial is to prove that the postoperative application of low-dose Landiolol significantly reduces the incidence of POAF without increased adverse events or hemodynamic instability compared to the placebo group after cardiac surgery in a non-Asian population.
- Conditions
- Atrial Fibrillation, Postoperative Complications
- Being tested
- Landiolol HCl, Placebo
- Keywords
- landiolol
- Medical subject headings
- Atrial Fibrillation, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Landiolol HClDrug
Also called Rapibloc
continous 2mcg/kg/min low dose application of Landiolol HCl for 72 hours
PlaceboDrug
Also called Isotone saline solution
continous application of isotone saline solution for 72 hours
| Study group | Role | What they receive |
|---|---|---|
| Landiolol group | Active comparator | Randomized patients receiving low dose landiolol after cardiac surgery Receives: Drug: Landiolol HCl |
| Placebo group | Placebo comparator | Randomized patients receiving 0,9% saline solution after cardiac surgery Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point is a combined endpoint consisting of the occurrence of atrial fibrillation and mortality during the initial 72 hours period after surgery
Death from any reason or the occurence of atrial in the holter ecg within 3 days after operation.
Measured: 3 days
Secondary outcomes (9)
Incidence/ frequency of occurrence of atrial fibrillation during the first seven days after cardiac surgery
The occurence of AF in the holter ecg in the 7 days after the operation
Measured: 7 days
Hemodynamic stability during treatment with IMP
Hemodynamic stability assessed with the need for vasoactive medication in the two groups within 7 days after operation
Measured: 7 days
Length of ICU stay
Postoperative length of stay in days in the icu
Measured: 30 days
Requirement of intensive respiratory and circulatory support
Length of invasive ventilation in hours or need for circulatory support
Measured: 30 days
Peri- and postoperative mortality
Peri- and postoperative mortality
Measured: 30 days
Assessment of biomarkers as surrogate parameters for cardiac dysfunction
Assessment of cardiac biomarkers to evaluate cardiac dysfunction
Measured: 30 days
Biomarker Assessment for cardiac injury, remodelling and fibrosis
Biomarker assessment (TropT, CK, CK-MB, sST-2) for cardiac remodelling, fibrosis, apoptosis and ischemia reperfusion injury at time of start of the surgery, at ICU admission, 24 hours after ICU admission, 3 days and 7 days after surgery.
Measured: 7 days
Incidence of serious adverse events
Incidence of serious adverse events
Measured: 30 days
Echocardiographic assessment for left ventricular function
Echocardiographic assessment for left ventricular systolic, diastolic and valvular function 7 days after surgery
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start21 Oct 2021
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Binder, Medical University of Vienna
- Investigators
- Andreas Binder, Principal investigator, Medical University of Vienna, Division of Cardiothoracic and Vascular Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084118
- Sponsor's protocol ID
- LAN_POAF_01
- Acronym
- LANDI-POAF
- Status last verified
- Oct 2021
- First submitted
- 18 May 2021
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double- Blind, Placebo- Controlled Study to Evaluate the Efficacy of Landiolol Hydrochloride for Prevention of Atrial Fibrillation in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05084118
- Acronym / sponsor ID
- LANDI-POAF / LAN_POAF_01
- Conditions
- Atrial Fibrillation, Postoperative Complications
- Keywords
- landiolol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 19 Oct 2021 (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 (POAF) is the most common arrhythmia after cardiac surgery with incidences ranging from 20% to 40% with the consequence of increasing mortality, morbidity, and hospital length of stay, as well as increasing the costs to the health care system. To prevent POAF the use of beta-blockers is suggested by the EACTA and ESC guidelines. Despite the prophylactic use, the discontinuation of beta-blockers in the perioperative period is a known risk factor that contributes to the occurrence of POAF. Due to the short half time and the highly beta-1-selective properties of Landiolol, it could be possible to initiate a betablocker for prevention in the immediate postoperative setting, without adverse effects like hypotension or severe bradycardia as seen with other betablockers like Metoprolol or even sometimes Esmolol.
Landiolol is already approved for the treatment of atrial tachycardias but is not yet approved for the use of prevention of POAF. In multiple previous studies the preventive potential of Landiolol in cardiac surgery could be proven in japanese study populations, with limitations due to limited sample sizes. In these trials the use of low-dose Landiolol effectively reduced the incidence of POAF without significant differences of increased side effects or in the hemodynamic stability compared to the placebo or standard of care groups.
The primary objective of this prospective, double-blind, randomized, placebo-controlled phase III trial is to prove that the postoperative application of low-dose Landiolol significantly reduces the incidence of POAF without increased adverse events or hemodynamic instability compared to the placebo group after cardiac surgery in a non-Asian population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Landiolol group | Active comparator | Drug: Landiolol HClRandomized patients receiving low dose landiolol after cardiac surgery |
| Placebo group | Placebo comparator | Drug: PlaceboRandomized patients receiving 0,9% saline solution after cardiac surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female patients ≥ 18 years old
- Written informed consent from patient
- Patients are in sinus rhythm
- Oral Betablocker in the patients long-term medication
- One of the following cardiac surgical procedures which is planned on cardiopulmonary bypass (CPB):
Key exclusion criteria (30 listed)
- Bodyweight > 101kg and/or BMI ≥ 40
- Cardiac surgery is planned as minimally invasive procedure (e.g., without thoracotomy or with lateral incision, minimal thoracotomy) or planned as off-pump surgery
- Planned maze procedure, radiofrequency ablation, pulmonary vein ablation, resection of the atrial appendix or atrial resections during the surgery
- Sinus bradycardia (resting heart rate < 50/min) at screening and before start of IMP treatment
- Second- or third-degree atrioventricular block at screening and before start of IMP treatment
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 |
|---|---|---|
| Landiolol HClAlso: Rapibloccontinous 2mcg/kg/min low dose application of Landiolol HCl for 72 hours | Drug | Landiolol group |
| PlaceboAlso: Isotone saline solutioncontinous application of isotone saline solution for 72 hours | Drug | Placebo group |
Primary outcome
The primary end point is a combined endpoint consisting of the occurrence of atrial fibrillation and mortality during the initial 72 hours period after surgery
Time frame: 3 days
Death from any reason or the occurence of atrial in the holter ecg within 3 days after operation.
9 secondary outcomes
Incidence/ frequency of occurrence of atrial fibrillation during the first seven days after cardiac surgery
Time frame: 7 days
Hemodynamic stability during treatment with IMP
Time frame: 7 days
Length of ICU stay
Time frame: 30 days
Requirement of intensive respiratory and circulatory support
Time frame: 30 days
Peri- and postoperative mortality
Time frame: 30 days
Assessment of biomarkers as surrogate parameters for cardiac dysfunction
Time frame: 30 days
Biomarker Assessment for cardiac injury, remodelling and fibrosis
Time frame: 7 days
Incidence of serious adverse events
Time frame: 30 days
Echocardiographic assessment for left ventricular function
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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RecruitingPhase 2
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Atrial Fibrillation (AF)
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.
Andreas Binder principal investigator
Medical University of Vienna, Division of Cardiothoracic and Vascular Anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Landiolol HCl in people with Atrial Fibrillation and Postoperative Complications, run by Medical University of Vienna at 1 site in Austria.
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 12 inclusion and 30 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 22 Oct 2021. 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 Austria. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Andreas Binder (0043 1 40400 64100, andreas.binder@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary end point is a combined endpoint consisting of the occurrence of atrial fibrillation and mortality during the initial 72 hours period after surgery (time frame: 3 days). 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 22 Oct 2021.