Comparison of the Administration of Levosimendan and Plac... | NCT01595737

Studies
Comparison of the Administration of Levosimendan and Placebo in the Preparation of Critical Patients for Heart Surgery

NCT01595737

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status

Completed

Last Update Posted

Mar 12, 2015Estimated

Enrollment

30Actual

Phase

Phase 4

Conditions

Cardiac Surgery

Interventions

Levosimendan
Placebo

Countries

Spain

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

May 2012

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

Feb 2011

Primary Completion Date

Nov 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

May 7, 2012

First Submission Date that Met QC Criteria

May 8, 2012

First Posted Date

May 10, 2012Estimated

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

Mar 11, 2015

Last Update Posted Date

Mar 12, 2015Estimated

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

This study aims to examine the efficacy of levosimendan in terms of reducing postoperative mortality and severe morbidity in patients undergoing non-emergent surgery for coronary revascularisation with or without ischaemic mitral regurgitation and who may or may not require repair or replacement of the mitral valve and have a LVEF < 35%.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

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

Name	Type	Description	Arm Group Labels	Other Names
Levosimendan	Drug	Levosimendan perfusion for 12 hours before surgery by a single route, at a dosage of 0.1µg/kg/min without receiving the loading dose.	Levosimendan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	Rate of mortality	30 days
Morbidity	Rate of morbidity	30 days

Secondary Outcomes

Measure	Description	Time Frame
Dose of inotropic drugs used	Requirements for inotropic drugs	30 days
Dose of vasoactive drugs used	Requirements for vasoactive drugs

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female > 18 years and < 85 years.
LVEF ≤ 35%
Indication for elective surgery for coronary revascularisation, with or without mitral valve repair.
Freely choose to participate in trial and sign an informed consent

Exclusion Criteria:

The patient does not accept the protocol.
Allergy (hypersensitivity) to levosimendan, any of its components or to riboflavin.
Severe hypotension or severe tachycardia prior to entering study.
Significant mechanical obstruction affecting ventricular filling and/or emptying.
History of Torsades.
Requirement for inotropic or vasoactive drugs or any type of mechanical assistance for 48 hours prior to surgery.
Onset of angina or acute myocardial infarction within 48 hours prior to surgery, or cardiogenic shock.
Surgery needs that are different from those planned.
Chronic or severe kidney failure requiring haemodialysis or peritoneal dialysis or creatinine clearance values below 30ml/min or presence of nephrotic syndrome.
Liver failure with transaminases 4 times above the normal maximum value.
The patient must undergo a concurrently scheduled surgery, such as for a valve other than the mitral.
When a screening cannot be performed at least during the 24 hours before surgery.
Uncontrolled diabetes mellitus (blood glucose > 24mmol/l or 432mg/dl).
History of any disease over the last five years that may compromise the patient's life, other than their heart disease.
The patient is currently abusing alcohol or toxic substances.
Presence of any other medical or psychiatric condition that the researcher believes makes a candidate ineligible for the study.
Women with childbearing potential who are not using an effective contraception method.
Participation in the last 30 days in any other study with either experimental drugs or devices.
Body Mass Index (BMI) greater than 35.
Administration of levosimendan in the last 30 days.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D006835	Hydrazones
D006834	Hydrazines
D009930	Organic Chemicals
D011724	Pyridazines