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

January 19, 2011 updated by: University Medical Center Nijmegen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GA
        • University Medical Center Nijmegen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Levosimendan
Active Comparator: Levosimendan
Drug: Levosimendan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Contractility of the diaphragm elicited with magnetic stimulation of the phrenic nerves
Time Frame: Multiple measurements within 4 hours after administration of study medication
Multiple measurements within 4 hours after administration of study medication
Fatiguability of the diaphragm
Time Frame: Multiple measurements within 4 hours after administration of study medication
Multiple measurements within 4 hours after administration of study medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Nijmegen

Collaborators

Orion Corporation, Orion Pharma

Investigators

  • Principal Investigator: Leo Heunks, MD, University Medical Center Nijmegen
  • Principal Investigator: Jonne Doorduin, University Medical Center Nijmegen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

April 9, 2010

First Submitted That Met QC Criteria

April 9, 2010

First Posted (Estimate)

April 12, 2010

Study Record Updates

Last Update Posted (Estimate)

January 20, 2011

Last Update Submitted That Met QC Criteria

January 19, 2011

Last Verified

September 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Levo1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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