NCT01101620

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 12, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

January 20, 2011

Status Verified

September 1, 2010

Enrollment Period

5 months

First QC Date

April 9, 2010

Last Update Submit

January 19, 2011

Conditions

Respiratory Muscle Function

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Levosimendan

ACTIVE COMPARATOR
Drug: Levosimendan

Placebo

PLACEBO COMPARATOR
Drug: Levosimendan

Interventions

LevosimendanDRUG
LevosimendanPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Nijmegen

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

MeSH Terms

Interventions

Simendan

Intervention Hierarchy (Ancestors)

HydrazonesHydrazinesOrganic ChemicalsPyridazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Leo Heunks, MD

    University Medical Center Nijmegen

    PRINCIPAL INVESTIGATOR

  • Jonne Doorduin

    University Medical Center Nijmegen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 9, 2010

First Posted

April 12, 2010

Study Start

April 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

January 20, 2011

Record last verified: 2010-09

Locations

NL(1)