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

University Medical Center Nijmegen

Status: Completed

Conditions: Respiratory Muscle Function

Treatments: Drug: Levosimendan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01101620

Levo1

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Levosimendan

Active Comparator group

Treatment:

Drug: Levosimendan

Placebo

Placebo Comparator group

Treatment:

Drug: Levosimendan