Heart Failure
Conditions
Keywords
HCV
Brief summary
To provide proof-of-concept data on the efficacy/safety of transplanting HCV positive donor grafts in HCV negative heart recipients who are currently listed.
Interventions
PROCEDUREProcedure: Heart Transplantation
A HCV negative or previously successfully treated recipient who recieves a HCV positive graft will be monitored. Patients who recieve an HCV graft will be treated for HCV according to accepted protocols.
Sponsors
Loma Linda University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female * Age 18 and older * Active on the transplant list * Donor organ with Antibody and NAT (nucleic acid test) positive for HCV * HCV negative recipient; this includes patients who never had HCV and those with HCV previously eradicated with antiviral therapy. The latter is defined as those with undetectable HCV viral load at least 3 months since stopping therapy. * Willing and able to provide written informed consent or for those subjects where hepatic encephalopathy affects their ability to provide initial or ongoing consent, has an appropriate and legally-authorized representative willing and able to provide consent on behalf of the subject * Patients listed for multiple organ transplant (heart and kidney or heart and liver) can be included based on agreement of non-cardiac organ transplant team
Exclusion criteria
* Participants co-infected with HIV * Donor previously treated with an NS5a containing regimen (if treatment history of donor known) * Known allergies or hypersensitivity to DAA or ribavarin * Pregnancy and/or actively breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient Survival Rate | 15 months |
Countries
United States
Outcome results
None listed