Donor Simvastatin Treatment in Organ Transplantation (NCT01160978) | Clinical Trial Compass
CompletedPhase 2/3
Donor Simvastatin Treatment in Organ Transplantation
Finland84 participantsStarted 2010-06-01
Plain-language summary
The aim of the study is to investigate the effects of donor simvastatin treatment on ischemia-reperfusion injury after heart transplantation.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Donor treatment with simvastatin reduces ischemia-reperfusion injury after heart transplantation