Effect of Levosimendan on Respiratory Muscle Function in Healthy Subjects

NCT ID: NCT01101620

Last Updated: 2011-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-09-30

Brief Summary

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

Detailed Description

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Conditions

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Respiratory Muscle Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Levosimendan

Group Type ACTIVE_COMPARATOR

Levosimendan

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Levosimendan

Intervention Type DRUG

Interventions

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Levosimendan

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Orion Corporation, Orion Pharma

INDUSTRY

Sponsor Role collaborator

University Medical Center Nijmegen

OTHER

Sponsor Role lead

Responsible Party

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University Medical Center Nijmegen

Principal Investigators

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Leo Heunks, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Nijmegen

Jonne Doorduin

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Nijmegen

Locations

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University Medical Center Nijmegen

Nijmegen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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Levo1

Identifier Type: -

Identifier Source: org_study_id

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