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NCT Number: NCT04493385

The Hepatitis C Transplant Collaborative

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.

Recruiting

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Key information

Conditions

Transplant; Failure, Heart Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Baylor Scott & White Health Research Institute

Dallas, Texas, 75246, United States

Location status: Recruiting

Location contact

Joost Felius, PhD

CONTACT

[email protected]

214-818-8943

About this study

Organ offers from donors with prior or chronic hepatitis C virus (HCV) exposure have been historically underutilized for orthotopic heart transplantation because of the post-transplantation risks [1, 2]. The use of HCV antibody-positive (Ab+) donors was associated with attenuated survival benefit after heart transplant and increased coronary allograft vasculopathy in the era before new highly effective direct-acting antiviral agents (DAAs) were developed [3-5]. These DAAs target multiple steps in the HCV replication life cycle [6]. Newer, well-tolerated, oral direct-acting antivirals (DAAs) have recently been transforming thoracic transplant outcomes after donor-derived HCV transmission. Moreover, now that HCV nucleic-acid testing (NAT), a polymerase chain reaction (PCR)-based approach to detecting viral activity, is widely available and used on all US donor organs, transplant centers have more relevant information about the donor, allowing better risk assessments.

As a result, the utilization of HCV NAT+ donor hearts for transplantation is rapidly gaining momentum, with the obvious benefits of an enlarged donor pool [7]. Appropriately, clinical safety trials are currently underway, including a multicenter effort led by the PI of this proposal. Moreover, since the last ~2 years many transplant centers across the nation have started transplanting HCV NAT+ donor organs as standard of care. We estimate that the number of HCV+ cardiac transplants is quickly outpacing the number of trial participants. Hence, it is imperative that safety assessments and risk analyses 'catch up with the real world'.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Recipient of a proven HCV NAT+ donor heart.
  • Re-transplant patients will be included.

Exclusion criteria

  • Multi-organ transplantation

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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

  3. Rate of Primary graft dysfunction (PGD)

    Time frame: 30 days

    Rate of Expected Post-Transplant Risks

  4. 1 year mortality

    Time frame: 1 Year

    Number of deaths

  5. Cellular graft rejection rate

    Time frame: 6.5 years

    Graft rejection rate

  6. Antibody Mediated Rejection rate

    Time frame: 6.5 years

    Graft rejection rate

Study contacts

Contact information is provided by the study sponsor or research team.

Joost Felius, PhD

CONTACT

[email protected]

214-818-8943

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Official study title

Nationwide Hepatitis C NAT+ Cardiac Transplant Experience

Important dates

Study start
2019
Primary completion
2030
Study completion
2030
First posted
Jul 30, 2020
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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