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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01101620
First Posted: April 12, 2010
Last Update Posted: January 20, 2011
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.
Collaborator:
Orion Corporation, Orion Pharma
Information provided by:
University Medical Center Nijmegen
  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
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Leo Heunks, University Medical Center Nijmegen
ClinicalTrials.gov Identifier: NCT01101620     History of Changes
Other Study ID Numbers: Levo1
First Submitted: April 9, 2010
First Posted: April 12, 2010
Last Update Posted: January 20, 2011
Last Verified: September 2010

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