NCT01721434

Brief Summary

Levosimendan is a relatively new drug that improves cardiac contractility in patients with heart failure. Its main mechanism of action is enhanced binding of calcium to the myocardial contractile proteins. Recent data from our lab showed that levosimendan improves contractility of human diaphragm in vitro (muscle fibers from COPD patient diaphragm) and in vivo (healthy subjects). Accordingly, levosimendan may appear of value in the treatment of disorders associated with impaired respiratory muscle function, such as mechanically ventilated patients.We hypothesize that levosimendan could improve respiratory muscle function in mechanically ventilated patients commencing a CPAP trial.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 5, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 10, 2015

Status Verified

June 1, 2015

Enrollment Period

3.7 years

First QC Date

September 21, 2012

Last Update Submit

June 9, 2015

Conditions

Muscle Weakness ConditionsWeaning Failure

Keywords

levosimendandiaphragm functionmechanically ventilated patientsneuro-mechanical efficiency

Outcome Measures

Primary Outcomes (1)

  • Neuro-mechanical efficiency of the diaphragm

    The primary outcome measure is the neuro-mechanical efficiency(i.e. the ratio of diaphragm electrical activity and transdiaphragmatic pressure) of the diaphragm during a continuous positive airway pressure (CPAP) trial.

    Artefact-free periode in the last 10 minutes of each CPAP trial

Secondary Outcomes (6)

  • Neuro-ventilatory efficiency of the diaphragm

    Artefact-free periode in the last 10 minutes of each CPAP trial

  • Oxygen consumption (VO2)

    Artefact-free periode in the last 10 minutes of each CPAP trial

  • Partial pressure of oxygen in arterial blood (PaO2)

    Last minute of the 30 minute CPAP trial

  • Accessory respiratory muscle activity

    Measured during a one hour protocol after the second CPAP trial.

  • Carbon dioxide production (VCO2)

    Artefact-free periode in the last 10 minutes of each CPAP trial

  • +1 more secondary outcomes

Study Arms (2)

Levosimendan

EXPERIMENTAL

Levosimendan 0.2 ug/kg/min intravenous for a single 7 hours.

Drug: Levosimendan

Placebo

PLACEBO COMPARATOR

Similar coloured placebo intravenous for a single 7 hours

Drug: Placebo

Interventions

LevosimendanDRUG
Also known as: Simdax
Levosimendan
PlaceboDRUG

Similar coloured placebo

Placebo

Eligibility Criteria

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

You may qualify if:

  • mechanical ventilation \> 3 days
  • informed consent
  • able to sustain a CPAP trial for 30 minutes
  • PaO2/FiO2 ratio \> 200 mmHg
  • ventilatory settings: positive end expiratory pressure \<= 10 cmH2O, pressure support \<= 10 cmH2O

You may not qualify if:

  • pre-existent muscle disease (congenital or acquired) or diseases/disorders known to be associated with myopathy including auto-immune diseases
  • pre-existent cardiac disease (based on history, electrocardiography and transthoracic echocardiography)
  • upper airway/esophageal pathology (i.e. recent surgery, esophageal varices, diaphragmatic hernia)
  • phrenic nerve lesions
  • pregnancy, breast feeding
  • severe renal failure (serum creatinine \> 150 umol/L)
  • severe hepatic failure
  • recent (within 5 days) nasal bleeding
  • systolic blood pressure \< 120 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500HB, Netherlands

RECRUITING

MeSH Terms

Interventions

Simendan

Intervention Hierarchy (Ancestors)

HydrazonesHydrazinesOrganic ChemicalsPyridazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Leo Heunks, MD, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leo MA Heunks, MD, PhD

CONTACT

024-3617273l.heunks@ic.umcn.nl

Jonne Doorduin, MSc

CONTACT

024-3617273j.doorduin@ic.umcn.nl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 21, 2012

First Posted

November 5, 2012

Study Start

September 1, 2012

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 10, 2015

Record last verified: 2015-06

Locations

NL(1)