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

This study has been completed.
Orion Corporation, Orion Pharma
Information provided by:
University Medical Center Nijmegen
ClinicalTrials.gov Identifier:
First received: April 9, 2010
Last updated: January 19, 2011
Last verified: September 2010
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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

ClinicalTrials.gov processed this record on May 26, 2016