Levosimendan in High Risk Patients Undergoing Cardiac Surgery (CHEETAH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Università Vita-Salute San Raffaele
Information provided by (Responsible Party):
Giovanni Landoni, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:
First received: October 7, 2009
Last updated: April 27, 2016
Last verified: March 2016
Low cardiac output syndrome (LCOs) is a serious complication in critically ill patients or those undergoing major surgery, resulting in multiple organ damage with significant in-hospital and long-term morbidity and mortality, as well as prolonged hospital stay. In this setting the mortality rate is distressingly high despite improvements in intensive care treatment, but survivors have an acceptable quality of life.

Condition Intervention Phase
Low Cardiac Output Syndrome
Drug: Levosimendan
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Levosimendan to Reduce Mortality in High Risk Cardiac Surgery Patients. A Multicentre Randomized Controlled Trial

Resource links provided by NLM:

Further study details as provided by Università Vita-Salute San Raffaele:

Primary Outcome Measures:
  • Mortality [ Time Frame: 30-days ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: November 2009
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
"Soluvit" ATC BO5XC (a mixture of vitamins with a yellow colour that is indistinguishable from the study drug Levosimendan) half ampul in 100 ml of glucose 5%
Drug: placebo
"Soluvit" ATC BO5XC (a mixture of vitamins with a yellow colour that is indistinguishable from the study drug Levosimendan) half ampul in 100 ml of glucose 5%
Experimental: Levosimendan
Drug: Levosimendan
Other Name: simdax

  Show Detailed Description


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Written informed consent
  • Age > 18 years
  • Perioperative myocardial dysfunction

Exclusion Criteria:

  • Previous unusual response to levosimendan or soluvit or any of their components
  • Inclusion in other randomised controlled studies in the previous 30 days
  • Levosimendan administration in the previous 30 days
  • Parkinson's disease
  • Emergency operation
  • Kidney or liver transplant
  • Liver cirrhosis (Child B or C)
  • Decision to use ECMO (ECMO already started or planned)
  • Do not resuscitate patient
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00994825

Contact: giovanni landoni, MD landoni.giovanni@hsr.it

Azienda Ospedaliera Ospedali Riuniti Papardo - Piemonte Not yet recruiting
Messina, ME, Italy, 98158
Contact: Maria C Zucchetti, MD         
A.O.U. Citta della Salute e della Scienza Recruiting
Torino, TO, Italy, 10126
Contact: Rosetta Lobreglio, MD         
A. O. Ordine Mauriziano di Torino Recruiting
Torino, TO, Italy
Contact: Marco Comis, MD         
Ospedale San Bortolo Not yet recruiting
Vicenza, VI, Italy
Contact: Stefano Auriemma, MD         
Policlinico S.Orsola-Malpighi Recruiting
Bologna, Italy, 40138
Contact: Massimo Baiocchi, MD    +39051214 ext 9092    massimo.baiocchi@aosp.bo.it   
Azienda Ospedaliera Universitaria "Mater Domini" Recruiting
Catanzaro, Italy
Contact: Gabriele Alvaro, MD       gabrielealvaro@libero.it   
Azienda Ospedaliera Universitaria San Martino Recruiting
Genova, Italy, 16132
Contact: Giuseppe Buscaglia, MD    +39010555 ext 5913    giuseppe.buscaglia@hsanmartino.it   
Ospedale San Raffaele di Milano, Italy Recruiting
Milano, Italy, 20132
Contact: giovanni landoni, MD         
Ospedale San Gerardo di Monza Not yet recruiting
Monza, Italy
Azienda Ospedaliera Specialistica dei Colli Recruiting
Napoli, Italy
Contact: Antonio Pisano, MD         
Azienda Ospedaliera Universitaria Pisana Recruiting
Pisa, Italy
Contact: Fabio Guarracino, MD       fabiodoc64@hotmail.com   
Azienda Ospedaliera Regionale San Carlo Recruiting
Potenza, Italy, 85100
Contact: Gianluca Paternoster, MD         
Ospedale Civile SS Annunziata Not yet recruiting
Sassari, Italy
Contact: Giovanni Pala, MD         
Russian Federation
Astrakhan Federal Centre for Cardiac Surgery Recruiting
Astrakhan, Russia, Russian Federation, 414000
Contact: Vadim Pasyuga, MD    +79270777 ext 229    vadimpas2000@mail.ru   
Scientific Research Institute for Complex Issues of Cardiovascular Diseases Recruiting
Kemerovo, Russia, Russian Federation, 650002
Contact: Evgeny Grigoryev, MD    +73842643 ext 604    grigorievev@mail.ru   
Moscow Regional Clinical & Research Institute Recruiting
Moscow, Russia, Russian Federation, 129110
Contact: Valery Likhvantsev, MD    +7495681 ext 5292    valery56@inbox.ru   
Research Institute of Circulation Pathology Recruiting
Novosibirsk, Russia, Russian Federation, 630055
Contact: Vladimir Lomivorotov, MD    +7383913916 ext 4103    vvlom@mail.ru   
Sponsors and Collaborators
Università Vita-Salute San Raffaele
Study Chair: Alberto Zangrillo, MD Vita-Salute University of Milano
  More Information

Additional Information:

Responsible Party: Giovanni Landoni, Head of Research, Anesthesia and Intensive Care Department, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier: NCT00994825     History of Changes
Other Study ID Numbers: GO/URC/ER/mm 768/DG 
Study First Received: October 7, 2009
Last Updated: April 27, 2016
Health Authority: Italy: Ministry of Health

Keywords provided by Università Vita-Salute San Raffaele:
cardiac surgery
cardiac anesthesia
inotropic drugs

Additional relevant MeSH terms:
Cardiac Output, Low
Cardiovascular Diseases
Heart Diseases
Signs and Symptoms
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Protective Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on May 30, 2016