Levosimendan Compassionate Use in Pediatric Patients With Advanced Decompensated Heart Failure
- Conditions
- Heart Decompensation
- Registration Number
- NCT02973620
- Lead Sponsor
- Tenax Therapeutics, Inc.
- Brief Summary
Open label study of levosimendan; planned comparison for effectiveness and safety to historic matched case controls from participating sites.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- 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
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Exclusion Criteria
- 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.
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Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method