PERIOPERATIVE LEVOSIMENDAN INFUSION IN PATIENTS WITH HEART FAILURE UNDERGOING NON-CARDIAC SURGERY: A PROSPECTIVE, RANDOMISED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER STUDY - SIMPLE

• Conditions: MedDRA version: 14.1Level: LLTClassification code 10007564Term: Cardiac failure, congestiveSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 14.1Level: LLTClassification code 10007562Term: Cardiac failure NOSSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 14.1Level: PTClassification code 10020100Term: Hip fractureSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]; Patients with serious cardiac failure scheduled for non-cardiac surgery; MedDRA version: 14.1Level: LLTClassification code 10006387Term: Broken hipSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 14.1Level: PTClassification code 10007559Term: Cardiac failure congestiveSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 14.1Level: PTClassification code 10007554Term: Cardiac failureSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 14.1Level: LLTClassification code 10066498Term: Cardiac failure chronic aggravatedSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 14.1Level: PTClassification code 10007558Term: Cardiac failure chronicSystem Organ Class: 10007541 - Cardiac disorders

• Registration Number: EUCTR2010-021263-33-SE
• Lead Sponsor: Sykehuset i Vestfold HF

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-25
• Last Update Posted: 1 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Inclusion Criteria
1.Patients scheduled for acute or elective surgery (there must be time for at least 2 hours of infusion of the study medication prior to the start of surgery)
2.The planned duration of the surgical procedure must be at least one (1) hour
3.The acute surgery has to be either implantation of hemi- or total hip prosthesis
4.The elective surgical procedure must be
Abdominal aortic surgery
Pheripheral surgery on arteries
Carotide surgery (trombenartectomy)
Intraabdominal and intrathoracal surgery
Ortopedic surgery on spine.
Implantation of hemi- or total prothesis - knee or hip.
Radical prostatectomy, transurethral excluded.
Cystectomy
Hysterectomy
Nephrectomy
5.A) Preoperative echovariable test performed within last 12 months prior to inclusion: EF = 35%. If an Acute myocardial infarction (AMI) last 12 months,the echocardiographic test must have been done > 1 months after an AMIor
B)Known cardiac failure.
6.NT-proBNP > 2000 pg/ml or 4000 pg/ml if renal failure (GFR<50)
7.The patient has to use at least one of these medicaments:
a.ACE- inhibitors
bAngiotensin receptor blockers
c.Diuretics
d.Digoxin/Digitoxin

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion Criteria
1.Patients under the age of 18
2.Patients participating in another pharmaceutical study
3.Known abuse of opioids, benzodiazepines, anti-epileptic drugs, a2-agonists or alcohol
4.Pregnant or breastfeeding women. Women of childbearing age must have a negative pregnancy test.
5.Acute myocardial infarction last month before admission
6.Cardiac failure as a result of hypertrophic cardiomyopathy
7.Verified severe aortic stenosis (aortic valve area < 1 cm2) or/and 50 mmHg (mean gradient)
8.Persistent ventricular tachycardia
9.History of torsades des pointes
10.Persistent heart rate > 120/minute
11.Systolic BP < 90 mmHg (non-invasive)
12.S-potassium < 3 mmol/l (treated low s-pottasium to > 3 mmol/l is not an exclusion)
13.Inability to give consent due to, e.g. dementia
14.Hypersensitivity to levosimendan or its excipients
15.Severe liver failure (known liver cirrhosis - Child-Pugh grade C)
16.Severe renal failure (GFR < 30 ml/minute or creatinine > 200 mmol/l). Treated prerenal failure with GFR >30 ml/minute or creatinine < 200 mmol/l is not an exclusion.
17.Prolonged QTc interval (men QTc > 0.43 s, women QTc > 0.45 s)
18.Patient not expected to fullfill the study period according to anesthesiologist estimation
19.Use of sulfonurea medication last 24 hours before inclusion
20. Planned use of ketamine.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified