Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
84 participants
INTERVENTIONAL
2010-06-01
2016-08-01
Brief Summary
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Detailed Description
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Simvastatin is administered to heart and/or lung donors through the nasogastric tube 4-6 hours prior to organ harvesting. Control organ donors do not receive simvastatin. The randomization and donor hospital instruction of the donor simvastatin treatment is performed by the transplant coordinator. All other caregivers and the transplant recipient are blinded to the treatment group allocation.
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.
In heart transplant recipients (n=42 in the donor simvastatin treatment group and n=42 in the control group), the primary end-point is postoperative cardiac enzyme serum levels (TnT, TnI, and CK-MB 1 hour, 6 hours, 12 hours and 24 hours after transplantation) and primary graft failure. Secondary end-points include peri- and postoperative parameters hemodynamics, short- and long term survival, biopsy-proven rejections, rejection treatments, and chronic rejection at 1, 5, 10, and 20 years after transplantation.
Lung, kidney and liver transplant recipients that have received organs from donors randomized to the control group or donor simvastatin group will also be followed for ischemia-reperfusion injury, perioperative organ function, innate and adaptive immunity and patient survival.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Simvastatin 80 mg group
The transplant recipients who have received an organ from donors treated with simvastatin 80 mg.
Simvastatin 80mg
The transplant recipients who have received an organ from donors treated with simvastatin 80 mg.
Control Rx
The transplant recipients who have received an organ from non-treated donors.
Control Rx
The transplant recipients who have received an organ from non-treated donors.
Interventions
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Simvastatin 80mg
The transplant recipients who have received an organ from donors treated with simvastatin 80 mg.
Control Rx
The transplant recipients who have received an organ from non-treated donors.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18-60 years
* Previously healthy
* No cholesterol medication
* Normal ECHO with LVEF \>45%, normal right ventricle and normal coronary angiography
* PiO2/FiO2 \> 40kPA, normal chest radiograph and normal bronchoscopy in lung donors
* Age between 18-70 for heart transplant recipients
* Male or female
* Listed for heart, lung, kidney, or liver transplantation
Exclusive Criteria for the recipient
* systemic sepsis
* a positive cross match
Exclusion Criteria
* High dose of inotropes (dopamine or dobutamine \> 20ug/kg/min or norepinephrine \>0.2 ug/kg/min) at the time of procurement
* Donor outside of the study country Finland
18 Years
70 Years
ALL
Yes
Sponsors
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University of Helsinki
OTHER
Academy of Finland
OTHER
Helsinki University Central Hospital
OTHER
Responsible Party
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Karl Lemstrom
Consultant Cardiothoracic Surgeon
Principal Investigators
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Karl B Lemstrom, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Cardiac surgery, Heart and Lung Center, Helsinki University Hospital
Locations
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Cardiac Surgery, Heart and Lung Center, Helsinki University Hospital
Helsinki, , Finland
Countries
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References
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Nykanen AI, Holmstrom EJ, Tuuminen R, Krebs R, Dhaygude K, Kankainen M, Jokinen JJ, Lommi J, Helantera I, Raisanen-Sokolowski A, Syrjala SO, Lemstrom KB. Donor Simvastatin Treatment in Heart Transplantation. Circulation. 2019 Aug 20;140(8):627-640. doi: 10.1161/CIRCULATIONAHA.119.039932. Epub 2019 Jul 29.
Related Links
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Website of Heart and Lung Center, Helsinki University Hospital
Website of Transplantation Laboratory, University of Helsinki
Other Identifiers
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T1020SIMVASTATIN
Identifier Type: -
Identifier Source: org_study_id