Effect of Levosimendan on Respiratory Muscle Function in... | NCT01101620

Studies
Effect of Levosimendan on Respiratory Muscle Function in Healthy Subjects

NCT01101620

Sponsor

University Medical Center Nijmegen

Status

Completed

Last Update Posted

Jan 20, 2011Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Respiratory Muscle Function

Interventions

Levosimendan

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Apr 9, 2010

First Submission Date that Met QC Criteria

Apr 9, 2010

First Posted Date

Apr 12, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2011

Last Update Posted Date

Jan 20, 2011Estimated

Name	Class
Orion Corporation, Orion Pharma	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Label	Type	Description	Intervention Names
Levosimendan	Active Comparator		Drug: Levosimendan
Placebo	Placebo Comparator		Drug: Levosimendan

Name	Type	Description	Arm Group Labels	Other Names
Levosimendan	Drug		Levosimendan Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leo Heunks, MD	University Medical Center Nijmegen	Principal Investigator
Jonne Doorduin	University Medical Center Nijmegen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center Nijmegen		Nijmegen	Gelderland	6525 GA	Netherlands

Intervention Browse Module

MeSH Terms

ID	Term
D000077464	Simendan

Ancestor Terms

ID	Term
D006835	Hydrazones
D006834	Hydrazines
D009930	Organic Chemicals
D011724	Pyridazines

Browse Leaves

Not provided

Browse Branches

Not provided