Muscle Weakness ConditionsPhase 2/3NCT01721434
Effects of Levosimendan on Diaphragm Function in Mechanically Ventilated Patients
A Phase 2/3 study testing Levosimendan in people with Muscle Weakness Conditions and Weaning Failure, run by University Medical Center Nijmegen at 1 site in Netherlands.
Trial summary
Levosimendan is a relatively new drug that improves cardiac contractility in patients with heart failure. Its main mechanism of action is enhanced binding of calcium to the myocardial contractile proteins. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Weakness Conditions, Weaning Failure
- What is being tested?
- Levosimendan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2012to May 2016
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mechanical ventilation > 3 days
- informed consent
- able to sustain a CPAP trial for 30 minutes
- PaO2/FiO2 ratio > 200 mmHg
- ventilatory settings: positive end expiratory pressure <= 10 cmH2O, pressure support <= 10 cmH2O
Who cannot join
- pre-existent muscle disease (congenital or acquired) or diseases/disorders known to be associated with myopathy including auto-immune diseases
- pre-existent cardiac disease (based on history, electrocardiography and transthoracic echocardiography)
- upper airway/esophageal pathology (i.e. recent surgery, esophageal varices, diaphragmatic hernia)
- phrenic nerve lesions
- pregnancy, breast feeding
- severe renal failure (serum creatinine > 150 umol/L)
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- severe hepatic failure
- recent (within 5 days) nasal bleeding
- systolic blood pressure < 120 mmHg
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6500HB
Leo MA Heunks, MD, PhD, 024-3617273, l.heunks@ic.umcn.nl
Jonne Doorduin, MSc, 024-3617273, j.doorduin@ic.umcn.nl
About this study
Levosimendan is a relatively new drug that improves cardiac contractility in patients with heart failure. Its main mechanism of action is enhanced binding of calcium to the myocardial contractile proteins. Recent data from our lab showed that levosimendan improves contractility of human diaphragm in vitro (muscle fibers from COPD patient diaphragm) and in vivo (healthy subjects). Accordingly, levosimendan may appear of value in the treatment of disorders associated with impaired respiratory muscle function, such as mechanically ventilated patients.We hypothesize that levosimendan could improve respiratory muscle function in mechanically ventilated patients commencing a CPAP trial.
- Conditions
- Muscle Weakness Conditions, Weaning Failure
- Being tested
- Levosimendan, Placebo
- Keywords
- levosimendan, diaphragm function, mechanically ventilated patients, neuro-mechanical efficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevosimendanDrug
Also called Simdax
PlaceboDrug
Similar coloured placebo
| Study group | Role | What they receive |
|---|---|---|
| Levosimendan | Experimental | Levosimendan 0.2 ug/kg/min intravenous for a single 7 hours. Receives: Drug: Levosimendan |
| Placebo | Placebo comparator | Similar coloured placebo intravenous for a single 7 hours Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuro-mechanical efficiency of the diaphragm
The primary outcome measure is the neuro-mechanical efficiency(i.e. the ratio of diaphragm electrical activity and transdiaphragmatic pressure) of the diaphragm during a continuous positive airway pressure (CPAP) trial.
Measured: Artefact-free periode in the last 10 minutes of each CPAP trial
Secondary outcomes (6)
Neuro-ventilatory efficiency of the diaphragm
A secondary outcome measure is the neuro-ventilatory efficiency (i.e. the ratio of diaphragm electrical activity and tidal volume) during a continuous positive airway pressure (CPAP) trial.
Measured: Artefact-free periode in the last 10 minutes of each CPAP trial
Oxygen consumption (VO2)
A secondary outcome measure is the oxygen consumption during a continuous positive airway pressure (CPAP) trial.
Measured: Artefact-free periode in the last 10 minutes of each CPAP trial
Partial pressure of oxygen in arterial blood (PaO2)
A secondary outcome measure is the PaO2 at the end of a continuous positive airway pressure (CPAP) trial.
Measured: Last minute of the 30 minute CPAP trial
Accessory respiratory muscle activity
To determine the effects of levosimendan on accessory respiratory muscle function, ventilator settings are adapted after the last CPAP-trial.
Measured: Measured during a one hour protocol after the second CPAP trial.
Carbon dioxide production (VCO2)
A secondary outcome measure is the carbon dioxide production during a continuous positive airway pressure (CPAP) trial.
Measured: Artefact-free periode in the last 10 minutes of each CPAP trial
Partial pressure of carbon dioxide in arterial blood (PaCO2)
A secondary outcome measure is the PaCO2 at the and of a continuous positive airway pressure (CPAP) trial.
Measured: Last minute of the 30 minute CPAP trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2012 (estimated)
- Study startSep 2012
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Weakness ConditionsStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Nijmegen
- Sponsor type
- University, hospital or other
- Collaborators
- Orion Corporation, Orion Pharma
- Responsible party
- Principal investigator, Leo Heunks, University Medical Center Nijmegen
- Investigators
- Leo Heunks, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721434
- Sponsor's protocol ID
- Levo2
- Status last verified
- Jun 2015
- First submitted
- 21 Sep 2012
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Levosimendan on Diaphragm Function in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT01721434
- Acronym / sponsor ID
- Levo2
- Conditions
- Muscle Weakness Conditions, Weaning Failure
- Keywords
- levosimendan, diaphragm function, mechanically ventilated patients, neuro-mechanical efficiency
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University Medical Center NijmegenUniversity, hospital or other
- Collaborators
- Orion Corporation, Orion Pharma
- Study start
- Sep 2012
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 5 Nov 2012 (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.
Levosimendan is a relatively new drug that improves cardiac contractility in patients with heart failure. Its main mechanism of action is enhanced binding of calcium to the myocardial contractile proteins. Recent data from our lab showed that levosimendan improves contractility of human diaphragm in vitro (muscle fibers from COPD patient diaphragm) and in vivo (healthy subjects). Accordingly, levosimendan may appear of value in the treatment of disorders associated with impaired respiratory muscle function, such as mechanically ventilated patients.We hypothesize that levosimendan could improve respiratory muscle function in mechanically ventilated patients commencing a CPAP trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levosimendan | Experimental | Drug: LevosimendanLevosimendan 0.2 ug/kg/min intravenous for a single 7 hours. |
| Placebo | Placebo comparator | Drug: PlaceboSimilar coloured placebo intravenous for a single 7 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- mechanical ventilation > 3 days
- informed consent
- able to sustain a CPAP trial for 30 minutes
- PaO2/FiO2 ratio > 200 mmHg
- ventilatory settings: positive end expiratory pressure <= 10 cmH2O, pressure support <= 10 cmH2O
Key exclusion criteria (9 listed)
- pre-existent muscle disease (congenital or acquired) or diseases/disorders known to be associated with myopathy including auto-immune diseases
- pre-existent cardiac disease (based on history, electrocardiography and transthoracic echocardiography)
- upper airway/esophageal pathology (i.e. recent surgery, esophageal varices, diaphragmatic hernia)
- phrenic nerve lesions
- pregnancy, breast feeding
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: Simdax | Drug | Levosimendan |
| PlaceboSimilar coloured placebo | Drug | Placebo |
Primary outcome
Neuro-mechanical efficiency of the diaphragm
Time frame: Artefact-free periode in the last 10 minutes of each CPAP trial
The primary outcome measure is the neuro-mechanical efficiency(i.e. the ratio of diaphragm electrical activity and transdiaphragmatic pressure) of the diaphragm during a continuous positive airway pressure (CPAP) trial.
6 secondary outcomes
Neuro-ventilatory efficiency of the diaphragm
Time frame: Artefact-free periode in the last 10 minutes of each CPAP trial
Oxygen consumption (VO2)
Time frame: Artefact-free periode in the last 10 minutes of each CPAP trial
Partial pressure of oxygen in arterial blood (PaO2)
Time frame: Last minute of the 30 minute CPAP trial
Accessory respiratory muscle activity
Time frame: Measured during a one hour protocol after the second CPAP trial.
Carbon dioxide production (VCO2)
Time frame: Artefact-free periode in the last 10 minutes of each CPAP trial
Partial pressure of carbon dioxide in arterial blood (PaCO2)
Time frame: Last minute of the 30 minute CPAP trial
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2015.
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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.
Leo Heunks, MD, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Levosimendan in people with Muscle Weakness Conditions and Weaning Failure, run by University Medical Center Nijmegen at 1 site in Netherlands.
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 5 inclusion and 9 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 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Leo MA Heunks, MD, PhD (024-3617273, l.heunks@ic.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuro-mechanical efficiency of the diaphragm (time frame: Artefact-free periode in the last 10 minutes of each CPAP trial). 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 10 Jun 2015.