Effect of Early Use of Levosimendan Versus Placebo on Top of a Conventional Strategy of Inotrope Use on a Combined Morbidity-mortality Endpoint in Patients With Cardiogenic Shock (LevoHeartShock)

July 31, 2025 updated by: Pr Bruno LEVY
Cardiogenic shock (CS) mortality remains high (40%). Despite their frequent use, few clinical outcome data are available to guide the initial selection of vasoactive drug therapies in patients with CS. Based on experts' opinions, the combination of norepinephrine-dobutamine is generally recommended as a first line strategy. Inotropic agents increase myocardial contractility, thereby increasing cardiac output. Dobutamine is commonly recommended to be the inotropic agent of choice and levosimendan is generally used following dobutamine failure. It may represent an ideal agent in cardiogenic shock, since it improves myocardial contractility without increasing cAMP or calcium concentration. At present, there are no convincing data to support a specific inotropic agent in patients with cardiogenic shock. Our hypothesis is that the early use of levosimendan, by enabling the discontinuation of dobutamine, would accelerate the resolution of signs of low cardiac output and facilitate myocardial recovery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
610

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Bordeaux, France
        • Recruiting
        • CHU Bordeaux
        • Contact:
          • Alexandre OUTARRA, MD-PhD
        • Principal Investigator:
          • Alexandre OUTARRA, Md-PhD
      • Creteil, France
        • Not yet recruiting
        • HENRI MONDOR -réanimation
        • Contact:
        • Principal Investigator:
          • Armand MEKONTSO DESSAP, MD-PhD
      • Dijon, France
        • Recruiting
        • CHU Dijon
        • Contact:
          • Pierre Grégoire GUINOT, MD-PhD
        • Principal Investigator:
          • Pierre Grégoire GUINOT, MD-PhD
      • La Tronche, France, 38700
        • Recruiting
        • CHU Grenoble -USIC
        • Contact:
          • Nicolas PILIERO, MD
        • Principal Investigator:
          • Nicolas PILIERO, MD
      • Marseille, France, 13385
        • Recruiting
        • AP-HM CHU La Timone
        • Contact:
          • Florent ARREGLE, MD
        • Principal Investigator:
          • Florent ARREGLE, MD
      • Montpellier, France, 34295
        • Recruiting
        • CHU Montpellier -hôpital Arnaud de Villeneuve
        • Contact:
          • Philippe GAUDARD, MD-PhD
        • Principal Investigator:
          • Philippe GAUDARD, MD-PhD
      • Paris, France, 75013
        • Recruiting
        • APHP, La Pitié Salpêtrière (medical intensive care unit)
        • Contact:
          • Alain Combes, MD
        • Principal Investigator:
          • Alain Combes, MD
      • Rouen, France
        • Recruiting
        • CHU Rouen
        • Contact:
          • Emmanuel BESNIER, MD-PhD
        • Principal Investigator:
          • Emmanuel BESNIER, MD-PhD
      • Strasbourg, France
        • Not yet recruiting
        • HU Strasbourg USIC
        • Contact:
        • Principal Investigator:
          • Olivier MOREL, MD-pHD
      • Vandoeuvre les Nancy, France
        • Recruiting
        • Chru Nancy
        • Contact:
          • Bruno Lévy, Prof
        • Principal Investigator:
          • Bruno LEVY, Prof
    • Bas-Rhin
      • Strasbourg, Bas-Rhin, France, 67091
        • Recruiting
        • CHRU Strasbourg -Nouvel Hôpital Civil
        • Contact:
          • Ferhat MEZIANI, MD-PhD
        • Principal Investigator:
          • Ferhat MEZIANI, MD-PhD
    • Bouches du Rhône
      • Marseille, Bouches du Rhône, France, 13015
        • Recruiting
        • AP-HM, Nord Hospital, Marseille
        • Contact:
          • Laurent Bonello, MD
        • Principal Investigator:
          • Laurent Bonello, MD
    • Calvados
      • Caen, Calvados, France, 14000
        • Not yet recruiting
        • CHU caen
        • Contact:
          • Katrien Blanchart, MD
        • Principal Investigator:
          • Katrien Blanchart, MD
    • Côte d'Or
      • Dijon, Côte d'Or, France, 21000
        • Recruiting
        • CHU Dijon
        • Contact:
          • Jean-Pierre Quenot, MD-PhD
        • Principal Investigator:
          • Jean-Pierre Quenot, MD-PhD
    • Doubs
      • Besançon, Doubs, France, 25000
        • Recruiting
        • CHU Besançon Jean Minjoz Hospital
        • Contact:
          • Hadrien WINISZEWSKI, MD
        • Principal Investigator:
          • Hadrien WINISZEWSKI, MD
    • Gard
      • Nîmes, Gard, France, 30029
        • Recruiting
        • CHU Nîmes, Carémeau Hospital
        • Contact:
          • Benoît Lattuca, MD
        • Principal Investigator:
          • Benoît Lattuca, MD
    • Gironde
      • Bordeaux, Gironde, France, 33600
        • Recruiting
        • CHU Bordeaux - Hôpital Haut-Lévêque
        • Contact:
          • Edouard Gerbaud, MD
        • Principal Investigator:
          • Edouard Gerbaud, MD
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • Recruiting
        • CHU de Toulouse
        • Contact:
          • Clément DELMAS, MD
        • Principal Investigator:
          • Clément Delmas, MD
    • Haute-Vienne
      • Limoges, Haute-Vienne, France, 87000
        • Recruiting
        • CHU Limoges, Dupuytren Hospital
        • Contact:
          • Philippe Vignon, MD
        • Principal Investigator:
          • Philippe Vignon, MD
    • Hérault
      • Montpellier, Hérault, France, 34090
        • Recruiting
        • CHU Montpellier, Arnaud de Villeneuve Hospital
        • Contact:
          • François Roubille, MD
        • Principal Investigator:
          • François Roubille, MD
    • Ille et Vilaine
      • Rennes, Ille et Vilaine, France, 35000
        • Recruiting
        • CHU Rennes, Pontchaillou Hospital
        • Contact:
          • Abdelkader BAKHTI, MD
        • Principal Investigator:
          • Abdelkader BAKHTI, MD
    • Isère
      • La Tronche, Isère, France, 38043
        • Recruiting
        • CHU Grenoble, Michallon Hospital
        • Contact:
          • Joanna Bougnaud, MD
        • Principal Investigator:
          • Joanna Bougnaud, MD
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44000
        • Recruiting
        • CHU Nantes
        • Contact:
          • Julien Plessis, MD
        • Principal Investigator:
          • Julien Plessis, MD
    • Moselle
      • Ars-Laquenexy, Moselle, France, 57245
        • Recruiting
        • CHR Metz-Thionville, Mercy Hospital
        • Contact:
          • Guillaume Louis, MD
        • Principal Investigator:
          • Guillaume LOUIS, MD
    • Nord
      • Lille, Nord, France, 59000
        • Recruiting
        • CHRU Lille, Cœur Poumon Institute
        • Contact:
          • Gilles LEMESLE, MD-PhD
        • Principal Investigator:
          • Gilles LEMESLE, MD-PhD
    • Rhône
      • Bron, Rhône, France, 69500
        • Recruiting
        • Hospices Civils de Lyon - Louis Pradel Hospital
        • Contact:
        • Principal Investigator:
          • Bertrand SCHEPPLER, MD
    • Val de Marne
      • Créteil, Val de Marne, France, 94010
        • Recruiting
        • APHP, Henri Mondor Hospital
        • Contact:
        • Principal Investigator:
          • Raphaelle HUGUET, MD
    • Vaucluse
      • Avignon, Vaucluse, France, 84000
        • Not yet recruiting
        • CH Henri Duffaut, Avignon
        • Contact:
          • Stéphane Andrieu, MD
        • Principal Investigator:
          • Stéphane Andrieu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Adult patient ≥ 18 years with cardiogenic shock defined by:

  • Adequate intravascular volume
  • Norepinephrine to maintain MAP at least at 65 mmHg for at least 3 hours and less than 24h. At inclusion the dose must be <1 microgram/kg/min under norepinephrine base or <2 microgram/kg/min under norepinephrine tartrate, OR/AND Dobutamine since at least 3h and less than 24h at inclusion.
  • Tissue hypoperfusion: at least 1 sign within 24h prior to inclusion (lactate ≥ 2 mmol/l; mottling, capillary refeel time > 3 seconds, oliguria <500ml/24h or ≤ 20 ml/h during the last 2 hours, ScVO2 ≤ 60% or veno-arterial PCO2 gap ≥ 5 mmHg);

Exclusion Criteria:

  • Myocardial sideration after cardiac arrest of non-cardiac etiology
  • Immediate or anticipated (within 6 hours) indication of Extra Corporel Life Support
  • Use of VA-ECMO or IMPELLA or LVAD;
  • Chronic renal failure requiring hemodialysis
  • Cardiotoxic poisoning
  • Septic cardiomyopathy
  • Previous levosimendan administration within 15 days
  • Cardiac arrest with non-shockable rhythm;
  • No flow time higher > 3 minutes;
  • Cardiac arrest with unknown no flow duration;
  • Total duration of cardiac arrest (no flow plus low flow) > 45 minutes;
  • Cerebral deficit with fixed dilated pupils
  • Patient moribund on the day of enrollment
  • Irreversible neurological pathology
  • Known hypersensitivity to levosimendan or placebo, or one of its excipients
  • Pregnant woman, birthing or breastfeeding mother
  • Minor (not emancipated)
  • Person deprived of liberty for judicial or administrative decision;
  • Adult subject to a legal protection measure (such as guardianship, conservatorship)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Levosimendan
Experimental group: patients with cardiogenic shock treated with levosimendan in addition to the conventional strategy.
Drug: Levosimendan 2.5 MG/ML Injectable Solution
Levosimendan will be diluted with Glucose G5%. The reconstitution of levosimendan will be performed, as close as possible to the start of the infusion. A continuous infusion of levosimendan will be administered over 24 h without bolus, started at a rate of 0.1 μg per kilogram of body weight per minute and, in both the persistence of hypoperfusion signs and in the absence of rate-limiting side effects, will be increased after 2 to 4 hours to a maximum of 0.2 μg per kilogram per minute for a further 20 to 22 hours.
Placebo Comparator: Placebo
Control group: Patients with cardiogenic shock treated with placebo (Cernevit/Soluvit) in addition to the conventional strategy.
Drug: Placebo
Placebo will be diluted with Glucose G5%. The reconstitution of Placebo will be performed, as close as possible to the start of the infusion. A continuous infusion of Placebo will be administered over 24 h without bolus, started at a rate of 0.1 μg per kilogram of body weight per minute and, in both the persistence of hypoperfusion signs and in the absence of rate-limiting side effects, will be increased after 2 to 4 hours to a maximum of 0.2 μg per kilogram per minute for a further 20 to 22 hours.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of All-cause mortality
Time Frame: Day 30 following randomization
Composite endpoint (i.e. All-cause Mortality and/or Extra Corporel Life Support implantation and/or dialysis)
Day 30 following randomization
Proportion of Extra Corporel Life Support implantation
Time Frame: Day 30 following randomization
Composite endpoint (i.e. All-cause Mortality and/or Extra Corporel Life Support implantation and/or dialysis)
Day 30 following randomization
Proportion of Dialysis
Time Frame: Day 30 following randomization
Composite endpoint (i.e. All-cause Mortality and/or Extra Corporel Life Support implantation and/or dialysis)
Day 30 following randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of intensive care unit stay
Time Frame: Up to Intensive Care Unit discharge (assessed up to 1 month)
Up to Intensive Care Unit discharge (assessed up to 1 month)
Duration of hospitalization
Time Frame: Up to hospitalization discharge (assessed up to 1 month)
Up to hospitalization discharge (assessed up to 1 month)
Time to death
Time Frame: Day 90
Prioritized composite endpoint with the following priority order: 1/ time to death, 2/ escalation to permanent left ventricular assist device or cardiac transplantation, 3/ dialysis, 4/ ECLS requirement, 5/ number of cardiovascular events (stroke, recurrent myocardial infarction, urgent coronary revascularization, re-hospitalization for heart failure).
Day 90
Time to escalation to permanent left ventricular assist device or cardiac transplantation
Time Frame: Day 90
Prioritized composite endpoint with the following priority order: 1/ time to death, 2/ escalation to permanent left ventricular assist device or cardiac transplantation, 3/ dialysis, 4/ ECLS requirement, 5/ number of cardiovascular events (stroke, recurrent myocardial infarction, urgent coronary revascularization, re-hospitalization for heart failure).
Day 90
Time to dialysis
Time Frame: Day 90
Prioritized composite endpoint with the following priority order: 1/ time to death, 2/ escalation to permanent left ventricular assist device or cardiac transplantation, 3/ dialysis, 4/ ECLS requirement, 5/ number of cardiovascular events (stroke, recurrent myocardial infarction, urgent coronary revascularization, re-hospitalization for heart failure).
Day 90
Time to ECLS requirement
Time Frame: Day 90
Prioritized composite endpoint with the following priority order: 1/ time to death, 2/ escalation to permanent left ventricular assist device or cardiac transplantation, 3/ dialysis, 4/ ECLS requirement, 5/ number of cardiovascular events (stroke, recurrent myocardial infarction, urgent coronary revascularization, re-hospitalization for heart failure).
Day 90
number of cardiovascular events
Time Frame: Day 90
Prioritized composite endpoint with the following priority order: 1/ time to death, 2/ escalation to permanent left ventricular assist device or cardiac transplantation, 3/ dialysis, 4/ ECLS requirement, 5/ number of cardiovascular events (stroke, recurrent myocardial infarction, urgent coronary revascularization, re-hospitalization for heart failure).
Day 90
Proportion of death.
Time Frame: Day 90
Day 90
Proportion of Extra Corporel Life Support implantation
Time Frame: Day 90
Day 90
Proportion of dialysis
Time Frame: Day 90
Day 90
Proportion of cardiac transplantation
Time Frame: Day 90
Day 90
Proportion of escalation to permanent Left Ventricular Assist Device
Time Frame: Day 90
Day 90
Proportion of stroke
Time Frame: Day 90
Day 90
Proportion of recurrent myocardial infarction
Time Frame: Day 90
Day 90
Proportion of urgent coronary revascularization
Time Frame: Day 90
Day 90
Proportion of re-hospitalization for heart failure
Time Frame: Day 90
Day 90
Proportion of All-cause mortality
Time Frame: Day 90
Composite endpoint of all-cause mortality and/or ECLS requirement and/or dialysis on day 90.
Day 90
Proportion of Extra Corporel Life Support implantation
Time Frame: Day 90
Composite endpoint of all-cause mortality and/or ECLS requirement and/or dialysis on day 90.
Day 90
Proportion of Dialysis
Time Frame: Day 90
Composite endpoint of all-cause mortality and/or ECLS requirement and/or dialysis on day 90.
Day 90
Number of dobutamine free days
Time Frame: From randomization to day 30
From randomization to day 30
Number of vasopressors free days
Time Frame: From randomization to day 30
From randomization to day 30
Number of ventilatory free days
Time Frame: From randomization to day 30
From randomization to day 30
Number of renal replacement free days
Time Frame: From randomization to day 90
From randomization to day 90
Lactate clearance
Time Frame: from randomization to day 7
from randomization to day 7
Proportion of All-cause mortality
Time Frame: days 7, 60, and 180 days and 12 months
Composite endpoint of all-cause mortality and/or ECLS requirement and/or dialysis
days 7, 60, and 180 days and 12 months
Proportion of Extra Corporel Life Support implantation
Time Frame: days 7, 60, and 180 days and 12 months
Composite endpoint of all-cause mortality and/or ECLS requirement and/or dialysis
days 7, 60, and 180 days and 12 months
Proportion of dialysis
Time Frame: days 7, 60, and 180 days and 12 months
Composite endpoint of all-cause mortality and/or ECLS requirement and/or dialysis
days 7, 60, and 180 days and 12 months
Number of renal replacement free days
Time Frame: D 30, 60, 180 and at 12 months
D 30, 60, 180 and at 12 months
Proportion of death
Time Frame: days 180 and at 12 months
days 180 and at 12 months
Proportion of Extra Corporel Life Support implantation
Time Frame: days 180 and at 12 months
days 180 and at 12 months
Proportion of dialysis
Time Frame: days 180 and at 12 months
days 180 and at 12 months
proportion of cardiac transplantation
Time Frame: days 180 and at 12 months
days 180 and at 12 months
proportion of escalation to permanent left ventricular assist device
Time Frame: days 180 and at 12 months
days 180 and at 12 months
Proportion of stroke
Time Frame: days 180 and at 12 months
days 180 and at 12 months
Proportion of recurrent myocardial infarction
Time Frame: days 180 and at 12 months
days 180 and at 12 months
Proportion urgent coronary revascularization
Time Frame: days 180 and at 12 months
days 180 and at 12 months
proportion of re-hospitalization for heart failure
Time Frame: days 180 and at 12 months
days 180 and at 12 months
Occurrence of arrhythmias requiring therapy
Time Frame: from randomization to intensive care unit discharge.
Occurrence of arrhythmias requiring therapy with anti-arrhythmic drugs or electric cardioversion (including atrial fibrillation, ventricular tachycardia, ventricular fibrillation, torsade de pointe)
from randomization to intensive care unit discharge.
the changes in biomarkers
Time Frame: from randomization to intensive care unit discharge.
From a dedicated biological collection on which we will measure existing and future biological parameters, we will evaluate the effect of Levosimendan on the changes in biomarkers between randomization and ICU/CCU discharge
from randomization to intensive care unit discharge.
All-cause mortality and/or ECLS and/or dialysis
Time Frame: Day 30
From a dedicated biological collection on which we will measure existing and future biological parameters, we will evaluate the ability of clinical and biological measure to predict levosimendan effect for the primary endpoint.
Day 30
All-cause mortality and/or ECLS and/or dialysis
Time Frame: At intensive care unit discharge
From a dedicated biological collection on which we will measure existing and future biological parameters, we will evaluate the ability of biological measure to predict subsequent outcome
At intensive care unit discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pr Bruno LEVY

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Clément DELMAS, Dr, CHU Toulouse
  • Study Chair: Nicolas GIRERD, Pr, Chru Nancy
  • Study Chair: Patrick ROSSIGNOL, Pr, Chru Nancy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 3, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 3, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 3, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-513811-29-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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