Heart DecompensationNCT02973620
Levosimendan Compassionate Use in Pediatric Patients With Advanced Decompensated Heart Failure
A study testing Levosimendan in people with Heart Decompensation, run by Tenax Therapeutics, Inc..
Trial summary
Open label study of levosimendan; planned comparison for effectiveness and safety to historic matched case controls from participating sites. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Heart Decompensation
- What is being tested?
- Levosimendan
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Heart Decompensation
- Being tested
- Levosimendan
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevosimendanDrug
Also called Simdax
levosimendan infusion started at 0.1 mcg/kg/min for 6-12 hours, increased to 0.2 mcg/kg/min for 24-36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DecompensationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Tenax Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973620
- Sponsor's protocol ID
- TNX-LVO-02
- Status last verified
- May 2018
- First submitted
- 22 Nov 2016
- Last updated
- 16 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Protocol; Intermediate Size Protocol: Levosimendan Compassionate Use in Pediatric Patients With Advanced Decompensated Heart Failure Who Are Refractory to Standard Therapy
- ClinicalTrials.gov ID
- NCT02973620
- Acronym / sponsor ID
- TNX-LVO-02
- Conditions
- Heart Decompensation
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Tenax Therapeutics, Inc.Industry (pharma, biotech, devices)
- First posted
- 25 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open label study of levosimendan; planned comparison for effectiveness and safety to historic matched case controls from participating sites.
Study design
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevosimendanAlso: Simdaxlevosimendan infusion started at 0.1 mcg/kg/min for 6-12 hours, increased to 0.2 mcg/kg/min for 24-36 hours | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Levosimendan in people with Heart Decompensation, run by Tenax Therapeutics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2018.