Phase 3 Heart Disease Trial, Recruiting NCT04020263 Sponsor: Pr Bruno LEVY Condition: Heart Disease
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Phase 3 Heart Disease Trial, Recruiting

NCT04020263
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older who are experiencing cardiogenic shock (a serious condition where the heart cannot pump enough blood to meet the body's needs)
  • People whose blood volume levels are considered adequate by their medical team
  • People who have been receiving a medication called norepinephrine (to keep blood pressure at a safe level) for at least 3 hours but less than 24 hours, at a dose below a specific threshold set by the trial, and/or have been receiving a heart-support medication called dobutamine for at least 3 hours but less than 24 hours
  • People showing at least one sign that their body tissues are not getting enough blood flow — such as elevated lactate levels in the blood, skin mottling, slow capillary refill, very low urine output, or low oxygen levels in the blood — detected within the 24 hours before joining the trial

Who may not be able to join:

  • People whose heart has been stunned as a result of a cardiac arrest that was caused by something other than a heart condition
  • People who need, or are expected to need within 6 hours, a type of life support machine that takes over the work of the heart and lungs (confirm with trial site)
  • People already using certain mechanical heart-support devices (VA-ECMO, IMPELLA, or LVAD)
  • People with long-term kidney failure who are already on dialysis
  • People whose heart condition is caused by poisoning with a substance toxic to the heart
  • People whose heart condition is caused by a severe infection (septic cardiomyopathy)
  • People who have received a medication called levosimendan within the past 15 days
  • People who have had a cardiac arrest with a non-shockable heart rhythm
  • People who had a cardiac arrest where the heart received no blood flow for more than 3 minutes before resuscitation began
  • People who had a cardiac arrest where the length of time with no blood flow is not known
  • People whose total cardiac arrest time (both the no-flow and low-flow periods combined) exceeded 45 minutes
  • People showing signs of severe brain damage, specifically fixed and dilated pupils
  • People considered to be in a terminal state on the day of enrolment
  • People with an irreversible neurological condition
  • People with a known allergy or sensitivity to levosimendan, placebo, or any of their ingredients
  • People who are pregnant, giving birth, or breastfeeding
  • People under the age of 18
  • People who are currently detained by a judicial or administrative order
  • Adults who are under a legal protection arrangement, such as guardianship or conservatorship

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Clément DELMAS, Dr, University Hospital, Toulouse

Phone: +33 3 83 15 40 84

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Pr Bruno LEVY
Registry
ClinicalTrials.gov
Start date
3 July 2023
Est. completion
3 February 2027

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Proportion of All-cause mortality; Proportion of Extra Corporel Life Support implantation; Proportion of Dialysis

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov