Cardiac ArrestPhase 1/2Beta-ArrestNCT05554978
Beta-blockade With Landiolol in Out-of-hospital Cardiac Arrest
A Phase 1/2 study testing Landiolol and Sodium Chloride (NaCl) 0.9% in people with Cardiac Arrest, run by Medical University of Vienna at 1 site in Austria.
Trial summary
This study investigates the efficacy of landiolol versus placebo in patients with out-of-hospital cardiac arrest (OHCA) and refractory ventricular fibrillation (electrical storm). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Landiolol and Sodium Chloride (NaCl) 0.9%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteAustria
- Study dates
- 3 Mar 2021to 31 Dec 2023
- Phase
- Phase 1/2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OHCA , >/=18 years of age
- 3 or more shockable rhythms (VF or pVT) and last rhythm shockable
Who cannot join
- Age > 85a
- Severe head trauma or acute active bleeding
- Known allergy or insensitivity to landiolol or another beta-blocker
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna
Georg Gelbenegger, MD, +43140400 ext. 29810, georg.gelbenegger@meduniwien.ac.at
Bernd Jilma, Prof, +43140400 ext. 29810, bernd.jilma@meduniwien.ac.at
About this study
Official title: Beta-blockade With Landiolol in Out-of-hospital Cardiac Arrest: a Randomized, Double-blind, Placebo-controlled, Pilot Trial
This study investigates the efficacy of landiolol versus placebo in patients with out-of-hospital cardiac arrest (OHCA) and refractory ventricular fibrillation (electrical storm).
Read the detailed description
The use of beta-blockers in OHCA patients with refractory VF could potentially reverse the unwanted beta-1-mediated effects of endogenous and exogenous epinephrine (proarrhythmic effect), which could in turn lead to a shorter time until return of spontaneous circulation (ROSC).
This is a prospective, double-blind, randomized placebo-controlled pilot trial. The investigators consider this a pilot trial, as this is the first prospective trial evaluating the use of beta-blockade in cardiac arrest.
- Conditions
- Cardiac Arrest
- Being tested
- Landiolol, Sodium Chloride (NaCl) 0.9%
- Keywords
- cardiac arrest, refractory, ventricular fibrillation, electrical storm, landiolol
- Medical subject headings
- Heart Arrest, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LandiololDrug
Also called Onoact, Rapibloc
patient receives landiolol in addition to standard-of-care
Sodium Chloride (NaCl) 0.9%Drug
Also called NaCl
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Landiolol | Experimental | initial dose: 20mg target dose: repeated dose (20mg) possible, max. 40mg (total) Receives: Drug: Landiolol |
| Placebo | Placebo comparator | Sodium Chlorid 0,9% Receives: Drug: Sodium Chloride (NaCl) 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to sustained return of spontaneous circulation (sROSC)
time from bolus infusion of landiolol OR placebo to sROSC
Measured: Time of sROSC or termination of resuscitation efforts
Secondary outcomes (10)
rate of sustained ROSC
number of sustained ROSC per included patients
Measured: Time of sROSC or termination of resuscitation efforts
number of shocks until sROSC
number of shocks until sROSC per included patients
Measured: Time of sROSC or termination of resuscitation efforts
rate of temporary ROSC (any ROSC)
number of temporary ROSC per included patients
Measured: Time of sROSC or termination of resuscitation efforts
survival to ICU admission
how many patients survived to ICU admission
Measured: Time of ICU admission or termination of resuscitation efforts
mean/median length of stay in ICU
in days
Measured: Time of transfer to open ward or death
mean/median length of hospital stay
in days
Measured: Time of hospital discharge or death
survival until hospital admission
how many patients were admitted alive to the hospital
Measured: Time of hospital admission or death
survival until hospital discharge
how many patients survived to hospital discharge
Measured: Time of hospital discharge or death
favorable neurologic outcome at hospital discharge, day 28, month 3, 6, 12 (CPC and mRS)
measured by CPC and mRS
Measured: at hospital discharge, day 28, month 3, 6, 12
survival at hospital discharge, day 28, month 3, 6, 12
how many patients survived to day 28, month 3, 6, 12
Measured: at hospital discharge, day 28, month 3, 6, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start3 Mar 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind, placebo-controlled pilot trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Holzer, Medical University of Vienna
- Investigators
- Michael M Holzer, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554978
- Sponsor's protocol ID
- Beta Blockade Cardiac Arrest
- Acronym
- Beta-Arrest
- Status last verified
- Mar 2023
- First submitted
- 19 Apr 2022
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: if requested, please address Georg Gelbenegger and Bernd Jilma
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta-blockade With Landiolol in Out-of-hospital Cardiac Arrest: a Randomized, Double-blind, Placebo-controlled, Pilot Trial
- ClinicalTrials.gov ID
- NCT05554978
- Acronym / sponsor ID
- Beta-Arrest / Beta Blockade Cardiac Arrest
- Conditions
- Cardiac Arrest
- Keywords
- cardiac arrest, refractory, ventricular fibrillation, electrical storm, landiolol
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 26 Sep 2022 (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.
This study investigates the efficacy of landiolol versus placebo in patients with out-of-hospital cardiac arrest (OHCA) and refractory ventricular fibrillation (electrical storm).
Detailed description
The use of beta-blockers in OHCA patients with refractory VF could potentially reverse the unwanted beta-1-mediated effects of endogenous and exogenous epinephrine (proarrhythmic effect), which could in turn lead to a shorter time until return of spontaneous circulation (ROSC).
This is a prospective, double-blind, randomized placebo-controlled pilot trial. The investigators consider this a pilot trial, as this is the first prospective trial evaluating the use of beta-blockade in cardiac arrest.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, double-blind, placebo-controlled pilot trial
| Arm | Type | Receives |
|---|---|---|
| Landiolol | Experimental | Drug: Landiololinitial dose: 20mg target dose: repeated dose (20mg) possible, max. 40mg (total) |
| Placebo | Placebo comparator | Drug: Sodium Chloride (NaCl) 0.9%Sodium Chlorid 0,9% |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- OHCA , >/=18 years of age
- 3 or more shockable rhythms (VF or pVT) and last rhythm shockable
Key exclusion criteria (3 listed)
- Age > 85a
- Severe head trauma or acute active bleeding
- Known allergy or insensitivity to landiolol or another beta-blocker
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: Onoact, Rapiblocpatient receives landiolol in addition to standard-of-care | Drug | Landiolol |
| Sodium Chloride (NaCl) 0.9%Also: NaClPlacebo | Drug | Placebo |
Primary outcome
Time to sustained return of spontaneous circulation (sROSC)
Time frame: Time of sROSC or termination of resuscitation efforts
time from bolus infusion of landiolol OR placebo to sROSC
10 secondary outcomes
rate of sustained ROSC
Time frame: Time of sROSC or termination of resuscitation efforts
number of shocks until sROSC
Time frame: Time of sROSC or termination of resuscitation efforts
rate of temporary ROSC (any ROSC)
Time frame: Time of sROSC or termination of resuscitation efforts
survival to ICU admission
Time frame: Time of ICU admission or termination of resuscitation efforts
mean/median length of stay in ICU
Time frame: Time of transfer to open ward or death
mean/median length of hospital stay
Time frame: Time of hospital discharge or death
survival until hospital admission
Time frame: Time of hospital admission or death
survival until hospital discharge
Time frame: Time of hospital discharge or death
favorable neurologic outcome at hospital discharge, day 28, month 3, 6, 12 (CPC and mRS)
Time frame: at hospital discharge, day 28, month 3, 6, 12
survival at hospital discharge, day 28, month 3, 6, 12
Time frame: at hospital discharge, day 28, month 3, 6, 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Department of Clinical PharmacologyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. if requested, please address Georg Gelbenegger and Bernd Jilma
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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.
Michael M Holzer, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Landiolol and Sodium Chloride (NaCl) 0.9% in people with Cardiac Arrest, 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 2 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: status not confirmed, as of the sponsor's last update on 17 Mar 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 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Georg Gelbenegger, MD (+43140400 ext. 29810, georg.gelbenegger@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to sustained return of spontaneous circulation (sROSC) (time frame: Time of sROSC or termination of resuscitation efforts). 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 17 Mar 2023.