NCT04493385

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
52mo left

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Sep 2019Dec 2030

Study Start

First participant enrolled

September 16, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 30, 2020

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

11.2 years

First QC Date

July 13, 2020

Last Update Submit

January 20, 2026

Conditions

Transplant; Failure, HeartHepatitis C

Outcome Measures

Primary Outcomes (6)

  • 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.

    6.5 years

  • Failure versus Cure Rate for HCV NAT+ Heart Transplants

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

    6.5 years

  • Rate of Primary graft dysfunction (PGD)

    Rate of Expected Post-Transplant Risks

    30 days

  • 1 year mortality

    Number of deaths

    1 Year

  • Cellular graft rejection rate

    Graft rejection rate

    6.5 years

  • Antibody Mediated Rejection rate

    Graft rejection rate

    6.5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cardiac transplant recipients utilizing HCV NAT+ donor organs

You may qualify if:

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

You may not qualify if:

  • \. Multi-organ transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor Scott & White Health Research Institute

Dallas, Texas, 75246, United States

RECRUITING

Related Publications (7)

  • 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.

    PMID: 21912770BACKGROUND

  • 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.

    PMID: 26615769BACKGROUND

  • 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.

    PMID: 17047214BACKGROUND

  • 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.

    PMID: 15019636BACKGROUND

  • 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.

    PMID: 27928718BACKGROUND

  • 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.

    PMID: 26725897BACKGROUND

  • 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.

    PMID: 29774177BACKGROUND

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Shelley A Hall, MD FACC

    BSWRI

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joost Felius, PhD

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2020

First Posted

July 30, 2020

Study Start

September 16, 2019

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

January 22, 2026

Record last verified: 2026-01

Locations

US(1)