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Heart drug tested to help patients escape life support

NCT ID NCT04158674

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

82 people

The number who actually took part.

Started

Feb 2020

Finished

Oct 2023

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • CHU Dijon Bourgogne

    Dijon, 21079, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.