Atrial FibrillationPhase 3MMELPOAFNCT03779178
Landiolol in Postoperative Atrial Fibrillation
A Phase 3 study testing Landiolol in people with Atrial Fibrillation, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Postoperative atrial fibrillation is a common complication after cardiac surgery and is associated with an elevation of morbidity and mortality. The recommended treatment includes heart rate control with a beta blocker. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Landiolol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2019to 4 Dec 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient underwent conventional cardiac surgery
- Age > 18 years
- Writing contentment
Who cannot join
- Pre-existing chronic atrial fibrillation
- Contraindication to beta-blockers
- Circulatory shock (cardiac index<2.2 L/min and lactate>4mmol/L)
- Distributive shock (cardiac index>2.2 L/min with norepinephrine dose > 0.3 µg/kg/min to reach mean arterial pressure > 65mmHg).
- Acute respiratory distress
- Major bleeding (>200mL/h)
Show all 10Show fewer
- Patient already included into an interventional clinical study
- Pregnancy
- No social security insurance
- Patient not able to give consent (curators, patients deprived of public rights)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microcirculatory and Macrocirculatory Effects of Landiolol in Prevention of Postoperative Atrial Fibrillation: a Randomized Study.
Postoperative atrial fibrillation is a common complication after cardiac surgery and is associated with an elevation of morbidity and mortality. The recommended treatment includes heart rate control with a beta blocker. Landiolol is a new-generation beta-blocker with favourable pharmacologic properties making an interesting drug to treat postoperative atrial fibrillation. However, Landiolol micro and macrocirculatory effects in the setting of atrial fibrillation are yet to describe. The aim of this study is to describe microcirculatory effects of incremental doses of landiolol in postoperative atrial fibrillation compared to a placebo. Our hypothesis is Landiolol will improve microcirculation disorders.
- Conditions
- Atrial Fibrillation
- Being tested
- Landiolol, Placebo
- Keywords
- landiolol, microcirculation, 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
Landiolol perfusion over 120 minutes in incremental doses : 0.5, 1, 2, 5 and 10 µg/kg/min. Doses are modified every 20 minutes
PlaceboDrug
Placebo perfusion is sodium chloride NaCl 0.9% over 120 minutes in incremental doses : 0.03, 0.06, 0.12, 0.3 and 0.6 mL/kg/h. Doses are modified every 20 minutes. Perfusion are similar in landiolol group to preserve blind.
| Study group | Role | What they receive |
|---|---|---|
| Landiolol group | Experimental | Landiolol perfusion in incremental doses (range 0.5 to 10 µg/kg/min) over 2 hours Receives: Drug: Landiolol |
| Placebo group | Placebo comparator | Placebo perfusion in incremental doses (range 0.03 to 0.6 mL/kg/h) over 2 hours Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
Tissular resaturation speed is measured after vascular occlusion test. At each time end-point, an occlusion of the arm blood flow with a tourniquet is made. After the nadir of the tissular saturation of the arm is reached the tourniquet is released and the resaturation speed is measured using the NIRS.
Measured: at 20 minutes
Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
Tissular resaturation speed is measured after vascular occlusion test. At each time end-point, an occlusion of the arm blood flow with a tourniquet is made. After the nadir of the tissular saturation of the arm is reached the tourniquet is released and the resaturation speed is measured using the NIRS.
Measured: at 40 minutes
Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
Tissular resaturation speed is measured after vascular occlusion test. At each time end-point, an occlusion of the arm blood flow with a tourniquet is made. After the nadir of the tissular saturation of the arm is reached the tourniquet is released and the resaturation speed is measured using the NIRS.
Measured: at 60 minutes
Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
Tissular resaturation speed is measured after vascular occlusion test. At each time end-point, an occlusion of the arm blood flow with a tourniquet is made. After the nadir of the tissular saturation of the arm is reached the tourniquet is released and the resaturation speed is measured using the NIRS.
Measured: at 80 minutes
Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
Tissular resaturation speed is measured after vascular occlusion test. At each time end-point, an occlusion of the arm blood flow with a tourniquet is made. After the nadir of the tissular saturation of the arm is reached the tourniquet is released and the resaturation speed is measured using the NIRS.
Measured: at 100 minutes
Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
Tissular resaturation speed is measured after vascular occlusion test. At each time end-point, an occlusion of the arm blood flow with a tourniquet is made. After the nadir of the tissular saturation of the arm is reached the tourniquet is released and the resaturation speed is measured using the NIRS.
Measured: at 120 minutes
Secondary outcomes (22)
Microcirculatory mean flow index (MIF) acquired by sublingual microscopy
Measured: at 120 minutes
proportion of perfused vessels acquired by sublingual microscopy
Measured: at 120 minutes
functional capillary density acquired by sublingual microscopy
Measured: at 120 minutes
De Backer score acquired by sublingual microscopy
Measured: at 120 minutes
heterogeneity of the mean flow index acquired by sublingual microscopy
Measured: at 120 minutes
Heart rate
hemodynamic parameters
Measured: at 120 minutes
systolic arterial pressure
hemodynamic parameters
Measured: at 120 minutes
diastolic arterial pressure
hemodynamic parameters
Measured: at 120 minutes
cardiac output measured by transthoracic echocardiography
hemodynamic parameters
Measured: at 120 minutes
systemic vascular resistance
hemodynamic parameters
Measured: at 120 minutes
arterial elastance.
hemodynamic parameters
Measured: at 120 minutes
Ejection fraction of the left ventricle (FEVG)
echocardiographic parameters
Measured: at 120 minutes
telesystolic volumes of the right ventricle
echocardiographic parameters
Measured: at 120 minutes
telesystolic volumes of the left ventricle
echocardiographic parameters
Measured: at 120 minutes
telediastolic volumes of the right ventricle
echocardiographic parameters
Measured: at 120 minutes
telediastolic volumes of the left ventricle
echocardiographic parameters
Measured: at 120 minutes
right ventricle contractility (measured with TAPSE and tricuspid S-wave)
echocardiographic parameters
Measured: at 120 minutes
intracardiac filling pressure profiles (E/a, E/Vp, E/e')
echocardiographic parameters
Measured: at 120 minutes
oxygen consumption (V02)
tissular perfusion parameters
Measured: at 120 minutes
oxygen delivery (DO2),
tissular perfusion parameters
Measured: at 120 minutes
carbon dioxide production (VCO2)
tissular perfusion parameters
Measured: at 120 minutes
arterial lactate
tissular perfusion parameters
Measured: at 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start17 Jan 2019
- Primary completion4 Dec 2019
- Study completion4 Dec 2019
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 Hospices Civils de LyonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias Jacquet-Lagrèze, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779178
- Sponsor's protocol ID
- 69HCL16_0743
- Other IDs
- 2018-000307-17, 2018
- Acronym
- MMELPOAF
- Status last verified
- Dec 2019
- First submitted
- 14 Dec 2018
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ferraris A, Jacquet-Lagreze M, Cazenave L, Fornier W, Jalalzai W, Rousseau-Saine N, Allaouchiche B, Junot S, Pozzi M, Fellahi JL; Anesthesie-Reanimation Coeur-Thorax-Vaisseaux (ARCOTHOVA) Group. Microcirculatory effects of landiolol: a double-blind, randomised, controlled study after cardiac surgery. Br J Anaesth. 2021 Jun;126(6):e212-e214. doi: 10.1016/j.bja.2021.03.013. Epub 2021 Apr 24. No abstract available.
PubMed 33902917
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microcirculatory and Macrocirculatory Effects of Landiolol in Prevention of Postoperative Atrial Fibrillation: a Randomized Study.
- ClinicalTrials.gov ID
- NCT03779178
- Acronym / sponsor ID
- MMELPOAF / 69HCL16_0743
- Conditions
- Atrial Fibrillation
- Keywords
- landiolol, microcirculation, cardiac surgery, atrial fibrillation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 4 Dec 2019 (actual)
- Study completion
- 4 Dec 2019 (actual)
- First posted
- 19 Dec 2018 (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 and is associated with an elevation of morbidity and mortality. The recommended treatment includes heart rate control with a beta blocker. Landiolol is a new-generation beta-blocker with favourable pharmacologic properties making an interesting drug to treat postoperative atrial fibrillation. However, Landiolol micro and macrocirculatory effects in the setting of atrial fibrillation are yet to describe. The aim of this study is to describe microcirculatory effects of incremental doses of landiolol in postoperative atrial fibrillation compared to a placebo. Our hypothesis is Landiolol will improve microcirculation disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Landiolol group | Experimental | Drug: LandiololLandiolol perfusion in incremental doses (range 0.5 to 10 µg/kg/min) over 2 hours |
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo perfusion in incremental doses (range 0.03 to 0.6 mL/kg/h) over 2 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient underwent conventional cardiac surgery
- Age > 18 years
- Writing contentment
Key exclusion criteria (10 listed)
- Pre-existing chronic atrial fibrillation
- Contraindication to beta-blockers
- Circulatory shock (cardiac index<2.2 L/min and lactate>4mmol/L)
- Distributive shock (cardiac index>2.2 L/min with norepinephrine dose > 0.3 µg/kg/min to reach mean arterial pressure > 65mmHg).
- Acute respiratory distress
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 |
|---|---|---|
| LandiololLandiolol perfusion over 120 minutes in incremental doses : 0.5, 1, 2, 5 and 10 µg/kg/min. Doses are modified every 20 minutes | Drug | Landiolol group |
| PlaceboPlacebo perfusion is sodium chloride NaCl 0.9% over 120 minutes in incremental doses : 0.03, 0.06, 0.12, 0.3 and 0.6 mL/kg/h. Doses are modified every 20 minutes. Perfusion are similar in landiolol group to preserve blind. | Drug | Placebo group |
Primary outcome
Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
Time frame: at 20 minutes
Tissular resaturation speed is measured after vascular occlusion test. At each time end-point, an occlusion of the arm blood flow with a tourniquet is made. After the nadir of the tissular saturation of the arm is reached the tourniquet is released and the resaturation speed is measured using the NIRS.
Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
Time frame: at 40 minutes
Tissular resaturation speed is measured after vascular occlusion test. At each time end-point, an occlusion of the arm blood flow with a tourniquet is made. After the nadir of the tissular saturation of the arm is reached the tourniquet is released and the resaturation speed is measured using the NIRS.
Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
Time frame: at 60 minutes
Tissular resaturation speed is measured after vascular occlusion test. At each time end-point, an occlusion of the arm blood flow with a tourniquet is made. After the nadir of the tissular saturation of the arm is reached the tourniquet is released and the resaturation speed is measured using the NIRS.
Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
Time frame: at 80 minutes
Tissular resaturation speed is measured after vascular occlusion test. At each time end-point, an occlusion of the arm blood flow with a tourniquet is made. After the nadir of the tissular saturation of the arm is reached the tourniquet is released and the resaturation speed is measured using the NIRS.
Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
Time frame: at 100 minutes
Tissular resaturation speed is measured after vascular occlusion test. At each time end-point, an occlusion of the arm blood flow with a tourniquet is made. After the nadir of the tissular saturation of the arm is reached the tourniquet is released and the resaturation speed is measured using the NIRS.
Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
Time frame: at 120 minutes
Tissular resaturation speed is measured after vascular occlusion test. At each time end-point, an occlusion of the arm blood flow with a tourniquet is made. After the nadir of the tissular saturation of the arm is reached the tourniquet is released and the resaturation speed is measured using the NIRS.
22 secondary outcomes
Microcirculatory mean flow index (MIF) acquired by sublingual microscopy
Time frame: at 120 minutes
proportion of perfused vessels acquired by sublingual microscopy
Time frame: at 120 minutes
functional capillary density acquired by sublingual microscopy
Time frame: at 120 minutes
De Backer score acquired by sublingual microscopy
Time frame: at 120 minutes
heterogeneity of the mean flow index acquired by sublingual microscopy
Time frame: at 120 minutes
Heart rate
Time frame: at 120 minutes
systolic arterial pressure
Time frame: at 120 minutes
diastolic arterial pressure
Time frame: at 120 minutes
cardiac output measured by transthoracic echocardiography
Time frame: at 120 minutes
systemic vascular resistance
Time frame: at 120 minutes
arterial elastance.
Time frame: at 120 minutes
Ejection fraction of the left ventricle (FEVG)
Time frame: at 120 minutes
telesystolic volumes of the right ventricle
Time frame: at 120 minutes
telesystolic volumes of the left ventricle
Time frame: at 120 minutes
telediastolic volumes of the right ventricle
Time frame: at 120 minutes
telediastolic volumes of the left ventricle
Time frame: at 120 minutes
right ventricle contractility (measured with TAPSE and tricuspid S-wave)
Time frame: at 120 minutes
intracardiac filling pressure profiles (E/a, E/Vp, E/e')
Time frame: at 120 minutes
oxygen consumption (V02)
Time frame: at 120 minutes
oxygen delivery (DO2),
Time frame: at 120 minutes
carbon dioxide production (VCO2)
Time frame: at 120 minutes
arterial lactate
Time frame: at 120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Results publication: PubMed 33902917Ferraris A, Jacquet-Lagreze M, Cazenave L, Fornier W, Jalalzai W, Rousseau-Saine N, Allaouchiche B, Junot S, Pozzi M, Fellahi JL; Anesthesie-Reanimation Coeur-Thorax-Vaisseaux (ARCOTHOVA) Group. Microcirculatory effects of landiolol: a double-blind, randomised, controlled study after cardiac surgery. Br J Anaesth. 2021 Jun;126(6):e212-e214. doi: 10.1016/j.bja.2021.03.013. Epub 2021 Apr 24. No abstract available.
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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.
Matthias Jacquet-Lagrèze principal investigator
Hospices Civils de Lyon
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 in people with Atrial Fibrillation, run by Hospices Civils de Lyon 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 6 Aug 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS) (time frame: at 20 minutes). The study lists 6 primary outcomes in all. 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 NCT03779178, 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 6 Aug 2025.