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Transplant; Failure, HeartNCT04493385

The Hepatitis C Transplant Collaborative

An observational study of Transplant; Failure, Heart and Hepatitis C, run by Baylor Research Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Transplant; Failure, Heart, Hepatitis C
How many people
500 participants
Where
1 siteUnited States
Study dates
16 Sep 2019to Dec 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Cardiac transplant recipients utilizing HCV NAT+ donor organs

Who may be able to join

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

Who cannot join

  • 1. Multi-organ transplantation

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Joost Felius, PhD contact

214-818-8943

Joost.Felius@BSWHEALTH.ORG

United States1 site, 1 recruiting

  • Baylor Scott & White Health Research Institute

    Dallas, Texas, 75246

    Joost Felius, PhD, 214-818-8943, Joost.Felius@BSWHEALTH.ORG

    Recruiting

Other trials in United States

About this study

Official title: Nationwide Hepatitis C NAT+ Cardiac Transplant Experience

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.

Read the detailed description

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'.

Medical subject headings
Hepatitis C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of donor HCV nucleic-acid testing positive (HCV NAT+) cardiac transplantation

    To assess the current status of donor HCV NAT+ cardiac transplantation via retrospective data collection.

    Measured: 6.5 years

  2. Failure versus Cure Rate for HCV NAT+ Heart Transplants

    sustained viral response (SVR)-12 (cure-rate) for HCV negative recipient

    Measured: 6.5 years

  3. Rate of Primary graft dysfunction (PGD)

    Rate of Expected Post-Transplant Risks

    Measured: 30 days

  4. 1 year mortality

    Number of deaths

    Measured: 1 Year

  5. Cellular graft rejection rate

    Graft rejection rate

    Measured: 6.5 years

  6. Antibody Mediated Rejection rate

    Graft rejection rate

    Measured: 6.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2020
  2. Study start16 Sep 2019
  3. Primary completionDec 2030 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04493385
Sponsor's protocol ID
019-297
Status last verified
Jan 2026
First submitted
13 Jul 2020
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kim EY, Ko HH, Yoshida EM. A concise review of hepatitis C in heart and lung transplantation. Can J Gastroenterol. 2011 Aug;25(8):445-8. doi: 10.1155/2011/947838.

    PubMed 21912770

  • Englum BR, Ganapathi AM, Speicher PJ, Gulack BC, Snyder LD, Davis RD, Hartwig MG. Impact of donor and recipient hepatitis C status in lung transplantation. J Heart Lung Transplant. 2016 Feb;35(2):228-35. doi: 10.1016/j.healun.2015.10.012. Epub 2015 Oct 9.

    PubMed 26615769

  • Gasink LB, Blumberg EA, Localio AR, Desai SS, Israni AK, Lautenbach E. Hepatitis C virus seropositivity in organ donors and survival in heart transplant recipients. JAMA. 2006 Oct 18;296(15):1843-50. doi: 10.1001/jama.296.15.1843.

    PubMed 17047214

  • Haji SA, Starling RC, Avery RK, Mawhorter S, Tuzcu EM, Schoenhagen P, Cook DJ, Ratliff NB, McCarthy PM, Young JB, Yamani MH. Donor hepatitis-C seropositivity is an independent risk factor for the development of accelerated coronary vasculopathy and predicts outcome after cardiac transplantation. J Heart Lung Transplant. 2004 Mar;23(3):277-83. doi: 10.1016/S1053-2498(03)00148-7.

    PubMed 15019636

  • Lee R, Kottilil S, Wilson E. Sofosbuvir/velpatasvir: a pangenotypic drug to simplify HCV therapy. Hepatol Int. 2017 Mar;11(2):161-170. doi: 10.1007/s12072-016-9776-8. Epub 2016 Dec 7.

    PubMed 27928718

  • Asselah T, Boyer N, Saadoun D, Martinot-Peignoux M, Marcellin P. Direct-acting antivirals for the treatment of hepatitis C virus infection: optimizing current IFN-free treatment and future perspectives. Liver Int. 2016 Jan;36 Suppl 1:47-57. doi: 10.1111/liv.13027.

    PubMed 26725897

  • Gottlieb RL, Hall SA. The New Direct Antiviral Agents and Hepatitis C in Thoracic Transplantation: Impact on Donors and Recipients. Curr Transplant Rep. 2018;5(2):145-152. doi: 10.1007/s40472-018-0192-y. Epub 2018 Apr 10.

    PubMed 29774177

Questions about this trial

What is this clinical trial studying?

An observational study of Transplant; Failure, Heart and Hepatitis C, run by Baylor Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Joost Felius, PhD (214-818-8943, Joost.Felius@BSWHEALTH.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of donor HCV nucleic-acid testing positive (HCV NAT+) cardiac transplantation (time frame: 6.5 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04493385, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.

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