Using hearts from donors with active hepatitis C (HCV NAT+) for transplantation
Nationwide Hepatitis C NAT+ Cardiac Transplant Experience
This tests whether receiving a heart from a donor with active hepatitis C (HCV NAT+) is safe and leads to acceptable outcomes for people having a heart transplant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Baylor Research Institute Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT04493385 on ClinicalTrials.gov |
What this trial studies
This is an observational registry of patients who received proven HCV NAT+ donor hearts, including re-transplant recipients, with multi-organ transplants excluded. The study will collect clinical safety and outcome data such as survival, coronary allograft vasculopathy, and antiviral treatment use following transplantation. It builds on the availability of nucleic-acid testing (NAT) for donors and the widespread use of well-tolerated direct-acting antivirals (DAAs) to treat donor-derived HCV. Data will be analyzed to see whether current practices using HCV NAT+ donor hearts produce acceptable short- and medium-term outcomes.
Who should consider this trial
Good fit: Ideal candidates are people who received a proven HCV NAT+ donor heart, including those undergoing re-transplantation, and who are treated at the enrolling center.
Not a fit: Patients who do not receive an HCV NAT+ donor heart or who are undergoing planned multi-organ transplantation would not be eligible and therefore would not benefit from this study.
Why it matters
Potential benefit: If successful, this could expand the pool of available donor hearts and allow more patients to receive timely transplants with comparable safety.
How similar studies have performed: Other centers and recent clinical reports have shown that using DAAs to treat donor-derived HCV after thoracic transplantation can be effective, and clinical safety efforts are underway nationally.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Recipient of a proven HCV NAT+ donor heart. 2. Re-transplant patients will be included. Exclusion Criteria: 1\. Multi-organ transplantation
Where this trial is running
Dallas, Texas
- Baylor Scott & White Health Research Institute — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Shelley A Hall, MD FACC — Bswri
- Study coordinator: Joost Felius, PhD
- Email: Joost.Felius@BSWHEALTH.ORG
- Phone: 214-818-8943
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.