Donor Simvastatin Treatment in Organ Transplantation (SIMVA)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Helsinki University
Academy of Finland
Information provided by (Responsible Party):
Janne J. Jokinen, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01160978
First received: July 12, 2010
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

The aim of the study is to investigate the effects of simvastatin treatment on ischemia-reperfusion injury in the context of cardiac-, lung-, kidney-, and liver transplantation.


Condition Intervention Phase
Heart Failure
Respiratory Failure
Liver Failure
Kidney Failure
Transplantation
Drug: Simvastatin
Drug: Placebo
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Official Title: Donor Simvastatin Treatment in Organ Transplantation

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • Preoperative donor simvastatin treatment reduces ischemia-reperfusion injury [ Time Frame: 0-20 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Preoperative donor simvastatin treatment reduces natural immune activity and the rate of rejection [ Time Frame: 0-20 years ] [ Designated as safety issue: Yes ]

Enrollment: 46
Study Start Date: June 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Simvastatin treatment group
The patients whose organ donor have received statin treatment prior transplantation
Drug: Simvastatin
80 mg simvastatin through nasogastric tube prior organ harvesting
Sham Comparator: Control
The patients whose organ donor has not received statin treatment prior organ transplantation
Drug: Placebo

Detailed Description:

The study hypothesis is that the per orally administered donor-related simvastatin treatment protects the transplanted organs for cold ischemia-related injury and ischemia-reperfusion injury. Also, it potentially decreases natural immune activity, rejection activation and thus improves long-term prognosis.

80 mg simvastatin is administered into donor circulation through the nasogastric tube 4-6 hours prior organ harvesting. The impact of donor simvastatin treatment is investigated and analyzed by several specific blood samples and biopsies that are taken from the recipient at the various time-points during the perioperative and postoperative phase. The randomized and blinded control group includes heart-, lung-, kidney-, and liver recipients whose organ donors have not received any statin medication prior organ harvesting.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Heart, lung, liver or kidney transplantation

Exclusion Criteria:

  • Preoperative statin treatment of the donor
  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: NCT01160978

Locations
Finland
Helsinki University Hospital. Dept. of Cardiothoracic Surgery
Helsinki, Finland, FI-00029
Sponsors and Collaborators
Helsinki University Central Hospital
Helsinki University
Academy of Finland
Investigators
Principal Investigator: Janne J Jokinen, MD, PhD Helsinki University Hospital, Dept. of Cardiothoracic Surgery
  More Information

Additional Information:
No publications provided

Responsible Party: Janne J. Jokinen, Consultant Cardiothoracic Surgeon, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01160978     History of Changes
Other Study ID Numbers: T1020SIMVASTATIN
Study First Received: July 12, 2010
Last Updated: June 19, 2014
Health Authority: Finland: Ethics Committee

Keywords provided by Helsinki University Central Hospital:
Transplantation
Simvastatin treatment
Ischemia-reperfusion injury
Lung failure

Additional relevant MeSH terms:
Respiratory Insufficiency
Heart Failure
Renal Insufficiency
Liver Failure
Respiration Disorders
Respiratory Tract Diseases
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014