Hearts from hepatitis c donors could save lives in organ shortage
NCT ID NCT03222531
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether hearts from donors with hepatitis C can be safely transplanted into people without the virus. Twenty adults with end-stage heart failure on the transplant waiting list will receive these hearts and take antiviral medication to prevent infection. The goal is to expand the pool of available donor hearts and reduce wait times.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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20 people
The number who actually took part.
- Started
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Aug 2017
- Finished
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Jun 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 71 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria (recipients): * End stage heart failure * Age ≥ 18 and \<71 years * Listed heart transplant at UPMC * Have panel reactive antibody level of \<98% * No obvious contraindication to liver transplant * Able to travel to UPMC for routine post-transplant visits and study visits for a minimum of 12 months after transplantation * Able to provide informed consent * Be willing to use a contraceptive method for a year after transplant Inclusion criteria (donors): * HCV antibody positive * HCV NAT negative or positive * Acceptable cardiac function for donation Exclusion criteria (recipients): * HIV positive * HCVAb or HCV RNA positive * Presence of behavioral risk factors for contracting HCV. These behavioral risk factors are current injection drug use, current intranasal illicit drug use, current percutaneous/parenteral exposures in an unregulated setting. * Hepatitis B surface antigen positive * History of liver cirrhosis * Persistently elevated liver transaminases, defined as ALT/AST at least 3 times the upper limit of normal for a minimum of 3 consecutive months * Waitlisted for a multi-organ transplant * Pregnant women * Known allergy to sofosbuvir/velpatasvir * Any condition, psychiatric or physical, that in the opinion of the investigator would make it unsafe to proceed with transplantation or interfere with the ability of the subject to participate in the study * Ongoing therapy with amiodarone for atrial or ventricular arrhythmia Prescribed use of Amiodarone Exclusion criteria (donors): * Confirmed HIV positive (positive HIV-1 antibody, positive HIV-2 antibody, positive p24 antigen and/or positive HIV NAT) * Confirmed HBV positive (positive hepatitis B surface antigen and/or HBV NAT) Known ongoing therapy for HCV
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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UPMC
Pittsburgh, Pennsylvania, 15213, United States
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Other studies related to the condition(s) this trial covers.
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