Effect of Levosimendan on Respiratory Muscle Function in Healthy Subjects (LSD1)
This study has been completed.
Sponsor:
University Medical Center Nijmegen
Collaborator:
Orion Corporation, Orion Pharma
Information provided by:
University Medical Center Nijmegen
ClinicalTrials.gov Identifier:
NCT01101620
First received: April 9, 2010
Last updated: January 19, 2011
Last verified: September 2010
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Purpose
The purpose of this study is to investigate if levosimendan improves contractile performance of the diaphragm in healthy subjects.
| Condition | Intervention |
|---|---|
|
Respiratory Muscle Function |
Drug: Levosimendan |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Pilot Study on the Effects of Levosimendan on in Vivo Respiratory Muscle Function in Healthy Subjects |
Further study details as provided by University Medical Center Nijmegen:
Primary Outcome Measures:
- 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 ]
| Enrollment: | 30 |
| Study Start Date: | April 2010 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Levosimendan | Drug: Levosimendan |
| Placebo Comparator: Placebo | Drug: Levosimendan |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- informed consent
Exclusion Criteria:
- 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
- upper airway / esophageal pathology
- phrenic nerve lesions
- any metals in body (pacemaker, splinters, metal stiches)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01101620
Locations
| Netherlands | |
| University Medical Center Nijmegen | |
| Nijmegen, Gelderland, Netherlands, 6525 GA | |
Sponsors and Collaborators
University Medical Center Nijmegen
Orion Corporation, Orion Pharma
Investigators
| Principal Investigator: | Leo Heunks, MD | University Medical Center Nijmegen |
| Principal Investigator: | Jonne Doorduin | University Medical Center Nijmegen |
More Information
No publications provided
| Responsible Party: | Leo Heunks, University Medical Center Nijmegen |
| ClinicalTrials.gov Identifier: | NCT01101620 History of Changes |
| Other Study ID Numbers: | Levo1 |
| Study First Received: | April 9, 2010 |
| Last Updated: | January 19, 2011 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Additional relevant MeSH terms:
|
Simendan Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Cardiotonic Agents |
Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vasodilator Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013