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

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiotonic Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 20, 2014