Acute Heart FailurePhase 2NCT01301313
Efficacy and Safety of Levosimendan in Severe Acute Heart Failure in Critical Children
A Phase 2 study testing Levosimendan and Conventional intensified inotropic treatment in people with Acute Heart Failure, run by Jose Luis Vazquez Martinez at 19 sites in Spain.
Trial summary
To evaluate the efficacy and safety of levosimendan versus conventional intensified inotropic treatment, in critical children with severe acute heart failure which persists despite of having received conventional inotropic treatment. Read more about this study
- Who is it for?
- Ages 24 hours to 18 years
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- Levosimendan and Conventional intensified inotropic treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 19 sitesSpain
- Study dates
- Feb 2011to Feb 2012
- Phase
- Phase 2
- 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 24 hours to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients who give written consent to participate in the study and for the transfer of material for cellular and molecular studies.
- Understand the purpose of the study and to be available to perform the procedures written in the protocol.
- Any child of 1 day old to 18 years old, admitted to the Paediatric Intensive Care Unit due to severe acute heart failure of any etiology.
Who cannot join
- All patients who
- express their wish of not to participate in the protocol
- have hypertrophic or restrictive cardiomyopathy
- have aortic Stenosis
- have a known allergy to any drug used in the study
- it is not possible to prescribe the study medication because it is contraindicated according to the Summary of the Product Characteristic or according to the criteria of the physician responsible for patient
- are pregnant
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Spain19 sites
Hospital Clínico Universitario de Santiago de Compostela
A Coruña, A Coruña
Hospital Juan Canalejo
A Coruña, A Coruña
Hospital San Joan de Deu
Barcelona, Barcelona
Hospital Universitario Reina Sofía
Córdoba, Córdoba
Hospital Donosti
Donostia / San Sebastian, San Sebastian
Hospital Universitario Ramon y Cajal
Madrid, Madrid, 28034
Hospital General Universitario Gregorio Marañón
Madrid, Madrid
Hospital Infantil La Paz
Madrid, Madrid
Hospital Universitario Doce de Octubre
Madrid, Madrid
Hospital Universitario Carlos Haya
Málaga, Malaga
Hospital Virgen de la Arrixaca
Murcia, Murcia
Hospital Clínico Universitario Son Dureta
Palma de Mallorca, Palma de Mallorca
Complejo Hospitalario Universitario de Salamanca
Salamanca, Salamanca
Hospital Virgen de la Salud
Toledo, Toledo
Hospital Clínico de Valencia
Valencia, Valencia
Hospital La Fe
Valencia, Valencia
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid
Hospital de Cruces
Vizcaya, Vizcaya
Hospital Miguel Servet
Zaragoza, Zaragoza
About this study
Official title: Phase II Study to Evaluate the Efficacy and Safety of Levosimendan in Severe Acute Heart Failure in Critical Children
To evaluate the efficacy and safety of levosimendan versus conventional intensified inotropic treatment, in critical children with severe acute heart failure which persists despite of having received conventional inotropic treatment.
- Conditions
- Acute Heart Failure
- Being tested
- Levosimendan, Conventional intensified inotropic treatment
- Keywords
- Acute heart failure, Children, Levosimendan, Inotropic treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevosimendanDrug
Levosimendan 2.5 mg / ml ampoules. The drug will be administrated in continuous intravenous perfusion in a single dose of 0.1 - 0.2 micrograms/ kg / min for 24 hours.
Conventional intensified inotropic treatmentDrug
Increasing the dose and / or the number of inotropes (dopamine and / or dobutamine and / or milrinone and / or adrenaline)
| Study group | Role | What they receive |
|---|---|---|
| Levosimendan | Experimental | Not described Receives: Drug: Levosimendan |
| Conventional intensified inotropic treatment | Active comparator | Not described Receives: Drug: Conventional intensified inotropic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic improvement at 24 hours
To evaluate the efficacy of levosimendan in the treatment of severe acute heart failure in children in critical conditions comparing the proportion of patients with hemodynamic improvement at 24 hours between the group who received levosimendan as rescue therapy (experimental treatment) versus the one who received intensified conventional inotropic treatment (control treatment)
Measured: 24 hours
Secondary outcomes (5)
Improvement in cardiac output
To compare the improvement in cardiac output induced by levosimendan in the treatment of severe acute heart failure in critical children versus the intensified conventional inotropic treatment, at 24 and 48h
Measured: 24 and 48 hours
Improvement in the neurohormonal profile
To compare the improvement in the neurohormonal profile (assessed as a reduction of BNP) induced by levosimendan in the treatment of severe acute heart failure in critical children versus the intensified conventional inotropic treatment, at 24 and 48h.
Measured: 24 and 48 hours
Number of days of hospital stay in paediatric intensive care unit
To compare the number of days of hospital stay in paediatric intensive care unit and the number of days on mechanical ventilation, at 30 days.
Measured: 30 days
Safety
To assess the safety of the use of levosimendan in the treatment of severe acute heart failure in children in critical conditions, at 30 days.
Measured: 30 days
Survival
Survival, at 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart FailureStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jose Luis Vazquez Martinez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jose Luis Vazquez Martinez, Hospital Universitario Ramon y Cajal
- Investigators
- Jose Luis Vazquez MArtinez, MD, Principal investigator, Hospital Universitario Ramón y Cajal. Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301313
- Sponsor's protocol ID
- LEVOPED1
- Other IDs
- 2009-017827-24, 2009
- Status last verified
- Jan 2013
- First submitted
- 22 Feb 2011
- Last updated
- 31 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Evaluate the Efficacy and Safety of Levosimendan in Severe Acute Heart Failure in Critical Children
- ClinicalTrials.gov ID
- NCT01301313
- Acronym / sponsor ID
- LEVOPED1
- Conditions
- Acute Heart Failure
- Keywords
- Acute heart failure, Children, Levosimendan, Inotropic treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Jose Luis Vazquez MartinezUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 23 Feb 2011 (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.
To evaluate the efficacy and safety of levosimendan versus conventional intensified inotropic treatment, in critical children with severe acute heart failure which persists despite of having received conventional inotropic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levosimendan | Experimental | Drug: Levosimendan |
| Conventional intensified inotropic treatment | Active comparator | Drug: Conventional intensified inotropic treatment |
Who may qualify
- Ages
- 24 hours to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients who give written consent to participate in the study and for the transfer of material for cellular and molecular studies.
- Understand the purpose of the study and to be available to perform the procedures written in the protocol.
- Any child of 1 day old to 18 years old, admitted to the Paediatric Intensive Care Unit due to severe acute heart failure of any etiology.
Key exclusion criteria (7 listed)
- All patients who
- express their wish of not to participate in the protocol
- have hypertrophic or restrictive cardiomyopathy
- have aortic Stenosis
- have a known allergy to any drug used in the study
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 |
|---|---|---|
| LevosimendanLevosimendan 2.5 mg / ml ampoules. The drug will be administrated in continuous intravenous perfusion in a single dose of 0.1 - 0.2 micrograms/ kg / min for 24 hours. | Drug | Levosimendan |
| Conventional intensified inotropic treatmentIncreasing the dose and / or the number of inotropes (dopamine and / or dobutamine and / or milrinone and / or adrenaline) | Drug | Conventional intensified inotropic treatment |
Primary outcome
Hemodynamic improvement at 24 hours
Time frame: 24 hours
To evaluate the efficacy of levosimendan in the treatment of severe acute heart failure in children in critical conditions comparing the proportion of patients with hemodynamic improvement at 24 hours between the group who received levosimendan as rescue therapy (experimental treatment) versus the one who received intensified conventional inotropic treatment (control treatment)
5 secondary outcomes
Improvement in cardiac output
Time frame: 24 and 48 hours
Improvement in the neurohormonal profile
Time frame: 24 and 48 hours
Number of days of hospital stay in paediatric intensive care unit
Time frame: 30 days
Safety
Time frame: 30 days
Survival
Time frame: 30 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
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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.
Jose Luis Vazquez MArtinez, MD principal investigator
Hospital Universitario Ramón y Cajal. Madrid
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Levosimendan and Conventional intensified inotropic treatment in people with Acute Heart Failure, run by Jose Luis Vazquez Martinez at 19 sites in Spain.
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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. 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.
What does the primary outcome measure?
Hemodynamic improvement at 24 hours (time frame: 24 hours). It is what the study was designed to measure, not a finding.
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 31 Jan 2013.