Effect of Levosimendan on Respiratory Muscle Function in Healthy Subjects

Respiratory Muscle Function Clinical Trial

— LSD1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01101620
• Other study ID #: Levo1
• Status: Completed
• Phase: N/A
• First received: April 9, 2010
• Last updated: January 19, 2011
• Start date: April 2010
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• Source: University Medical Center Nijmegen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Muscle Function

Intervention

Drug:
• Levosimendan

Locations

Country	Name	City	State
Netherlands	University Medical Center Nijmegen	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Nijmegen	Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contractility of the diaphragm elicited with magnetic stimulation of the phrenic nerves		Multiple measurements within 4 hours after administration of study medication
Primary	Fatiguability of the diaphragm		Multiple measurements within 4 hours after administration of study medication