Respiratory Muscle FunctionLSD1NCT01101620
Effect of Levosimendan on Respiratory Muscle Function in Healthy Subjects
A study testing Levosimendan in people with Respiratory Muscle Function, run by University Medical Center Nijmegen at 1 site in Netherlands.
Trial summary
The purpose of this study is to investigate if levosimendan improves contractile performance of the diaphragm in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Muscle Function
- What is being tested?
- Levosimendan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2010to Sep 2010
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- informed consent
Who cannot join
- use of any prescript medication
- chronic hiccups
- pre-existent muscle disease (congenital or acquired) or diseases / disorders know to be associated with myopathy including diabetes and auto-immune diseases.
- pre-existent lung disease
- pre-existent cardiac disease (based on history, electrocardiography and transthoracic echocardiography)
- pregnancy, breast feeding
Show all 9Show fewer
- upper airway / esophageal pathology
- phrenic nerve lesions
- any metals in body (pacemaker, splinters, metal stiches)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Nijmegen
Nijmegen, Gelderland, 6525 GA
About this study
Official title: Pilot Study on the Effects of Levosimendan on in Vivo Respiratory Muscle Function in Healthy Subjects
The purpose of this study is to investigate if levosimendan improves contractile performance of the diaphragm in healthy subjects.
- Conditions
- Respiratory Muscle Function
- Being tested
- Levosimendan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevosimendanDrug
| Study group | Role | What they receive |
|---|---|---|
| Levosimendan | Active comparator | Not described Receives: Drug: Levosimendan |
| Placebo | Placebo comparator | Not described Receives: Drug: Levosimendan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contractility of the diaphragm elicited with magnetic stimulation of the phrenic nerves
Measured: Multiple measurements within 4 hours after administration of study medication
Fatiguability of the diaphragm
Measured: Multiple measurements within 4 hours after administration of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Muscle FunctionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Nijmegen
- Sponsor type
- University, hospital or other
- Collaborators
- Orion Corporation, Orion Pharma
- Investigators
- Leo Heunks, MD, Principal investigator, University Medical Center NijmegenJonne Doorduin, Principal investigator, University Medical Center Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101620
- Sponsor's protocol ID
- Levo1
- Acronym
- LSD1
- Status last verified
- Sep 2010
- First submitted
- 9 Apr 2010
- Last updated
- 20 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Effects of Levosimendan on in Vivo Respiratory Muscle Function in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01101620
- Acronym / sponsor ID
- LSD1 / Levo1
- Conditions
- Respiratory Muscle Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Medical Center NijmegenUniversity, hospital or other
- Collaborators
- Orion Corporation, Orion Pharma
- Study start
- Apr 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 12 Apr 2010 (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.
The purpose of this study is to investigate if levosimendan improves contractile performance of the diaphragm in healthy subjects.
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 | Active comparator | Drug: Levosimendan |
| Placebo | Placebo comparator | Drug: Levosimendan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- informed consent
Key exclusion criteria (9 listed)
- use of any prescript medication
- chronic hiccups
- pre-existent muscle disease (congenital or acquired) or diseases / disorders know to be associated with myopathy including diabetes and auto-immune diseases.
- pre-existent lung disease
- pre-existent cardiac disease (based on history, electrocardiography and transthoracic echocardiography)
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 |
|---|---|---|
| Levosimendan | Drug | Levosimendan, Placebo |
Primary outcome
Contractility of the diaphragm elicited with magnetic stimulation of the phrenic nerves
Time frame: Multiple measurements within 4 hours after administration of study medication
Fatiguability of the diaphragm
Time frame: Multiple measurements within 4 hours after administration of study medication
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2011.
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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 principal investigator
University Medical Center Nijmegen
Jonne Doorduin principal investigator
University Medical Center Nijmegen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levosimendan in people with Respiratory Muscle Function, 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 1 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: finished, as of the sponsor's last update on 20 Jan 2011. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Contractility of the diaphragm elicited with magnetic stimulation of the phrenic nerves (time frame: Multiple measurements within 4 hours after administration of study medication). The study lists 2 primary outcomes in all. 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 20 Jan 2011.