Donor Simvastatin Treatment in Organ Transplantation

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to investigate the effects of donor simvastatin treatment on ischemia-reperfusion injury after heart transplantation.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Helsinki University Central Hospital
• Collaborators: Academy of Finland; Helsinki University; University of Helsinki
• Treatments: Simvastatin

Criteria

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