CClinicalTrials.gg
Status unknownNCT04938375SeLeBêtaUpdated Jun 24, 2021

Safety Profile of the Combination of Levosimendan and IV Beta Blocker in Cardiogenic Shock: a Retrospective Study

An observational study in Cardiogenic Shock and Arrythmia, sponsored by Central Hospital, Nancy, France. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-24.

Sponsored by Central Hospital, Nancy, France · Observational

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
25
Ages
18 Years and older
Sex
All
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Study summary

The purpose of this study is to assess the safety profile of the combination of Levosimendan and beta blocker in cardiogenic shock with arrythmia.

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Conditions studied

  • Cardiogenic Shock
  • Arrythmia
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In context

Shock, Cardiogenic

277 studies on the registry are indexed under Shock, Cardiogenic; 127 are open to participants now.

This study's planned enrollment of 25 is below the median of 200 across 142 observational studies indexed under Shock, Cardiogenic.

Browse Shock, Cardiogenic studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients admitted to the ICU for cardiogenic shock who received esmolol or landiolol within 7 days of a levosimendan treatment

Inclusion criteria

  • Adult patients admitted to the ICU for cardiogenic shock who received esmolol or landiolol within 7 days of a levosimendan treatment

Exclusion criteria

Exclusion Criteria:

  • Patient's opposition
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
25 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. To record adverse events and observe the safety profile of patients in cardiogenic shock who received concomitant treatment with Levosimendan and IV beta blocker

    Incidence of adverse events leading to discontinuation of beta blocker: bradycardia/high-grade atrioventricular block/hypotension/noradrenaline increase/crystalloid resuscitation

    Time frame: From the start of the beta blocker until 7 days after the start of the Levosimendan treatment

Secondary outcomes

  1. Measure cardiac rhythm control; Measure heart rate control; Measure beta blocker dosages administered without adverse effects; Measure veno-arterial extra corporeal membranous oxygenation weaning rate; Measure resuscitation mortality

    Description of adverse events related to beta blocker Efficacy of beta blocker (rhythm and/or rate control) Time to resolution after discontinuation of beta blocker in case of adverse event Maximum dosage of well-tolerated beta blocker; Evolution of the haemodynamic profile in the hours following the introduction of the beta blocker Resuscitation mortality Weaning from veno-arterial ECMO at D7 of Levosimendan treatment

    Time frame: From the start of the beta blocker until 7 days after the start of the Levosimendan treatment ; Haemodynamic changes will be recorded every 2 hours from the start of the beta blocker

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04938375
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Sponsor
First posted
Jun 24, 2021
Start date
Jan 1, 2016
Primary completion
Jun 30, 2021 (estimated)
Completion
Jul 30, 2021 (estimated)
Last update
Jun 24, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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