Effect of Levosimendan on Respiratory Muscle Function in Healthy Subjects (LSD1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01101620
Recruitment Status : Completed
First Posted : April 12, 2010
Last Update Posted : January 20, 2011
Orion Corporation, Orion Pharma
Information provided by:
University Medical Center Nijmegen

Brief Summary:
The purpose of this study is to investigate if levosimendan improves contractile performance of the diaphragm in healthy subjects.

Condition or disease Intervention/treatment Phase
Respiratory Muscle Function Drug: Levosimendan Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Study on the Effects of Levosimendan on in Vivo Respiratory Muscle Function in Healthy Subjects
Study Start Date : April 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Arm Intervention/treatment
Active Comparator: Levosimendan Drug: Levosimendan
Placebo Comparator: Placebo Drug: Levosimendan

Primary Outcome Measures :
  1. Contractility of the diaphragm elicited with magnetic stimulation of the phrenic nerves [ Time Frame: Multiple measurements within 4 hours after administration of study medication ]
  2. Fatiguability of the diaphragm [ Time Frame: Multiple measurements within 4 hours after administration of study medication ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01101620

University Medical Center Nijmegen
Nijmegen, Gelderland, Netherlands, 6525 GA
Sponsors and Collaborators
University Medical Center Nijmegen
Orion Corporation, Orion Pharma
Principal Investigator: Leo Heunks, MD University Medical Center Nijmegen
Principal Investigator: Jonne Doorduin University Medical Center Nijmegen

Responsible Party: Leo Heunks, University Medical Center Nijmegen Identifier: NCT01101620     History of Changes
Other Study ID Numbers: Levo1
First Posted: April 12, 2010    Key Record Dates
Last Update Posted: January 20, 2011
Last Verified: September 2010

Additional relevant MeSH terms:
Anti-Arrhythmia Agents
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protective Agents
Physiological Effects of Drugs