Strategies To Prevent Cardiac Allograft Vasculopathy Related Events in Heart Transplant Recipients

• Status: Withdrawn
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

1. Early initiation of sirolimus will prevent or delay the development of intimal thickening and subsequent graft failure.

2. Treatment guided by the development of cardiac allograft vasculopathy (CAV) on intravascular ultrasound (IVUS) will be more effective in delaying progression of CAV compared to treatment guided by angiography.

3. Prevention of the development and progression of intimal thickness on IVUS will prevent the development of heart failure, graft dysfunction, and cardiovascular death related to CAV.

4. Small artery elasticity predicts progression of cardiac allograft vasculopathy and is modified by sirolimus

5. Patients who have no progression of CAV will have favorable improvement in biomarkers and endothelial cells compared to patients who have progression of CAV

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria

For Prospective Arm:

• 18 years or older

• Successful orthotropic heart transplant within 6 months of enrollment

Inclusion Criteria

For Retrospective Arm:

• 18 years or older

• Successful orthotropic heart transplant within 6 months to 3 years of enrolment

• Less than moderate CAV by angiogram or IVUS

Exclusion Criteria

For Prospective Arm:

• Greater than minimal baseline coronary disease

• Chronic kidney disease with creatinine >2mg/dl

• Baseline (1 month) ejection fraction < 50%

• IV contrast allergy

• Rejection within 3 months of enrollment

• Sensitivity to sirolimus or its derivatives

• Prior sirolimus use

Exclusion Criteria

For Retrospective Arm:

• Significant baseline (one month) coronary artery disease (>50% in one or more vessels by angiogram or MIT >0.5 by IVUS)

• Chronic kidney disease with creatinine >2mg/dl

• Baseline (1 month) ejection fraction < 50%

• IV contrast allergy

• Rejection within 3 months prior to enrollment

• Sensitivity to sirolimus or its derivatives

• Prior sirolimus use