Status:
COMPLETED
Donor Simvastatin Treatment in Organ Transplantation
Lead Sponsor:
Helsinki University Central Hospital
Collaborating Sponsors:
University of Helsinki
Academy of Finland
Conditions:
Heart Failure
Respiratory Failure
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
The aim of the study is to investigate the effects of donor simvastatin treatment on ischemia-reperfusion injury after heart transplantation.
Detailed Description
The study hypothesis of the single center randomized double-blinded clinical trial is that donor simvastatin treatment reduces ischemia-reperfusion injury after heart transplantation. Also, it potenti...
Eligibility Criteria
Inclusion
- Inclusion criteria for a donor:
- Heart transplant donor
- 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
- Exclusion Criteria for the heart/lung donor:
- Severe left ventricular hypertrophy \> 14 mm
- 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
- Inclusion criteria for a transplant recipient:
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT01160978
Start Date
June 1 2010
End Date
August 1 2016
Last Update
September 19 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cardiac Surgery, Heart and Lung Center, Helsinki University Hospital
Helsinki, Finland, FI-00029