Expanding the Pool in Orthotopic Heart Transplantation

• Status: Recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, pilot trial to test the safety and efficacy of transplantation of hearts from HCV seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) donors to HCV seronegative recipients on the heart transplant waitlist. Treatment and prophylaxis will be administered, using a transmission-triggered approach for the first scenario (HCV Ab+/NAT- donors, arm 1) and a prophylaxis approach for the later scenario (HCV Ab+/NAT+ donors, arm 2).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mary E. Keebler, MD; University of Pittsburgh
• Treatments: Sofosbuvir; Velpatasvir

Criteria

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