Levosimendan Compassionate Use in Pediatric Patients With Advanced Decompensated Heart Failure

May 10, 2018 updated by: Tenax Therapeutics, Inc.

Expanded Access Protocol; Intermediate Size Protocol: Levosimendan Compassionate Use in Pediatric Patients With Advanced Decompensated Heart Failure Who Are Refractory to Standard Therapy

Open label study of levosimendan; planned comparison for effectiveness and safety to historic matched case controls from participating sites.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
No longer available

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.
Expanded Access

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

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

General Eligibility

All patients must meet at least one of the following definitions of failed standard therapy of decompensated heart failure:

Definition for failure of standard therapy:

  1. Decompensated heart failure refractory to standard therapy (Milrinone of ≥0.5mcg/kg/min for >48 hours with EF <35%) including any of the following:

    • (SaO2 - SmVO2) > 30 % or lactate >3 AND/OR
    • Need for second inotropic agent AND/OR
    • Need for positive pressure ventilation AND
    • Patient not qualifying for long term ventricular assist device support or transplant at the time of assessment.

  2. Cardiogenic shock with acute decompensated heart failure (requiring positive pressure ventilation and addition of inotropic support with or without use of Milrinone with EF <35%) refractory to therapy for more than 48h including any or all of the following:

    • (SaO2 - SmVO2) > 30 % or lactate >3
    • Patient not qualifying for long term ventricular assist device support or transplant at the time of assessment.
    • Potential need for short-term mechanical circulatory support.
  3. Failure to wean off ECMO support with use of standard inotropic / vasoconstrictor support.

Inclusion Criteria:

  1. Male or female, ≤18 years of age with acute or acute on chronic decompensated heart failure.
  2. Male or female, ≤18 years of age on ECMO support and unable to wean from ECMO support.
  3. Informed Consent signed by the subject's parents or their legally acceptable representatives indicating that they understand the purpose of and procedures required for expanded access and are willing to participate in the study.
  4. Patients meeting one of the following definitions of failed standard therapy of decompensated heart failure

Exclusion Criteria:

  1. Patients < 36 weeks gestational age
  2. Patients weighing < 2 kg
  3. Obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade
  4. Estimated glomerular filtration rate (eGRF) < 30 mL/min/1.73m2.
  5. Known allergic reaction or sensitivity to levosimendan or excipients.
  6. A history of Torsades de Pointes, uncorrectable hypo- or hyperkalemia, uncorrectable hypo- or hypercalcemia
  7. Pregnant, suspected to be pregnant, or breast-feeding.
  8. Inability or unwillingness of subject or legal guardian/representative to give written informed consent.

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?

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.
Tenax Therapeutics, Inc.

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 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).
November 22, 2016

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.
November 22, 2016

First Posted (Estimate)

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.
November 25, 2016

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.
May 16, 2018

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.
May 10, 2018

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.
May 1, 2018

More Information

Terms related to this study

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.
  • TNX-LVO-02

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings