Heart drug tested to help patients escape life support
NCT ID NCT04158674
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a drug called levosimendan to see if it could help people with severe heart failure successfully come off a temporary heart-lung machine (ECLS). The trial planned to include 82 adults who were ready to try weaning off the machine. Half would get the drug and half a placebo. The study was stopped early, so results are limited.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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82 people
The number who actually took part.
- Started
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Feb 2020
- Finished
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Oct 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * adult patient * patient or person responsible for the patient has given written consent * patient with acute circulatory heart failure under ECLS * patient meeting criteria for ECLS withdrawal * ECLS flow rate at 1.0-1.5l/min and/or ECLS pump rpm ≤ 1500 rpm * LVEF \> 20% in cardiac ultrasound and aortic ITV \> 10 cm * VIS score ≤ 10 * Arterial lactates ≤ 2 mmol/l * Right ventricular outflow tract shortening fraction \> 30% * Basal diameter at the tricuspid telediastolic ring of the right ventricle \< 35 mm * Fraction of inspired oxygen combined between ventilator and ECLS \< 80% * ECLS withdrawl scheduled within 48 hours * Absence of an initial or progressive infectious episode (no planned introduction of antibiotic therapy within 48 hours prior to inclusion) Exclusion Criteria: * Patient with hepatic insufficiency: cytolysis at least 20 times normal * Drug intoxication and attempted suicide * Patient with a contraindication to the use of levosimendan: * hypersensitivity to the active substance or any of the excipients * severe hypotension and ventricular tachycardia * significant mechanical obstructions affecting ventricular filling and/or ejection * severe renal failure (creatinine clearance \< 30 ml/min) * severe liver failure (TP\<50%) * history of torsades de pointes * Patient with a contraindication to the use of CERNEVIT®: * hypersensitivity to active substances, in particular to vitamin B1 or to one of the excipients or to soy protein products or to peanut protein products * hypervitaminosis to any vitamin contained in this formulation * severe hypercalcemia, hyper calciuria, tumour, bone metastasis, primary hyperparathyroidism, granulomatosis * patient not affiliated to or not benefiting from national health insurance * patient subject to legal protection (curatorship, guardianship) * patient subject to limited judicial protection * pregnant, parturient or breastfeeding woman
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHU Dijon Bourgogne
Dijon, 21079, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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