NCT04493385 · Baylor Research Institute
The Hepatitis C Transplant Collaborative
What this study is about
In this study we seek to test the hypothesis that safety and clinical outcomes after cardiac transplantation utilizing HCV NAT+ donor organs as currently performed are acceptable.
View original scientific description
In this study we seek to test the hypothesis that safety and clinical outcomes after cardiac transplantation utilizing HCV NAT+ donor organs as currently performed are acceptable.
Primary outcome measures
Number of donor HCV nucleic-acid testing positive (HCV NAT+) cardiac transplantation
Time frame: 6.5 years
To assess the current status of donor HCV NAT+ cardiac transplantation via retrospective data collection.
Failure versus Cure Rate for HCV NAT+ Heart Transplants
Time frame: 6.5 years
sustained viral response (SVR)-12 (cure-rate) for HCV negative recipient
Rate of Primary graft dysfunction (PGD)
Time frame: 30 days
Rate of Expected Post-Transplant Risks
1 year mortality
Time frame: 1 Year
Number of deaths
Cellular graft rejection rate
Time frame: 6.5 years
Graft rejection rate
Antibody Mediated Rejection rate
Time frame: 6.5 years
Graft rejection rate
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Recipient of a proven HCV NAT+ donor heart.
- Re-transplant patients will be included.
Exclusion criteria
- 1\. Multi-organ transplantation
Where
- Dallas, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 22, 2026 · Source of record for eligibility and locations