Levosimendan Compassionate Use in Pediatric Patients With Advanced Decompensated Heart Failure

NCT02973620 | Unknown

• 1 other identifier: TNX-LVO-02
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Heart Decompensation

Interventions

Levosimendan DRUG

levosimendan infusion started at 0.1 mcg/kg/min for 6-12 hours, increased to 0.2 mcg/kg/min for 24-36 hours

Also known as: Simdax

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female, ≤18 years of age with acute or acute on chronic decompensated heart failure.
• Male or female, ≤18 years of age on ECMO support and unable to wean from ECMO support.
• 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.
• Patients meeting one of the following definitions of failed standard therapy of decompensated heart failure

You may not qualify if:

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

Sponsors & Collaborators

• Tenax Therapeutics, Inc.: lead

MeSH Terms

Conditions

Heart Failure

Interventions

Simendan

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hydrazones; Hydrazines; Organic Chemicals; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: November 25, 2016
• Last Updated: May 16, 2018

Record last verified: 2018-05