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Completed

NCT Number: NCT01101620

Effect of Levosimendan on Respiratory Muscle Function in Healthy Subjects

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

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Key information

Conditions

Respiratory Muscle Function

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Nijmegen

Nijmegen, Gelderland, 6525 GA, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Levosimendan

Drug

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Medical Center Nijmegen

Other

Collaborators

  • Orion Corporation, Orion Pharma

Registry information

Official study title

Pilot Study on the Effects of Levosimendan on in Vivo Respiratory Muscle Function in Healthy Subjects

Acronym: LSD1

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 12, 2010
Registry last updated
Jan 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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