Effect of Levosimendan on Respiratory Muscle Function in Healthy Subjects

Not Applicable

Completed

• Conditions: Respiratory Muscle Function
• Interventions: Drug: Levosimendan

• Registration Number: NCT01101620
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-09
• Study First Submitted QC: 2010-04-09
• Study First Posted: 2010-04-12
• Status Verified: 2010-09
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Last Update Submitted: 2011-01-19
• Last Update Posted: 2011-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• informed consent

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Levosimendan	-
Levosimendan	Levosimendan	-

Primary Outcome Measures

Name	Time	Method
Contractility of the diaphragm elicited with magnetic stimulation of the phrenic nerves	Multiple measurements within 4 hours after administration of study medication
Fatiguability of the diaphragm	Multiple measurements within 4 hours after administration of study medication

Trial Locations

Locations (1)

University Medical Center Nijmegen; 🇳🇱 Nijmegen, Gelderland, Netherlands