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Effect of Levosimendan on Respiratory Muscle Function in Healthy Subjects

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01101620
Acronym
LSD1
Enrollment
30
Registered
2010-04-12
Start date
2010-04-30
Completion date
2010-09-30
Last updated
2011-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Muscle Function

Brief summary

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

Interventions

DRUGLevosimendan

Sponsors

Orion Corporation, Orion Pharma
CollaboratorINDUSTRY
University Medical Center Nijmegen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
Contractility of the diaphragm elicited with magnetic stimulation of the phrenic nervesMultiple measurements within 4 hours after administration of study medication
Fatiguability of the diaphragmMultiple measurements within 4 hours after administration of study medication

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026