Expanding the Pool in Orthotopic Heart Transplantation (NCT03222531) | Clinical Trial Compass
CompletedPhase 2
Expanding the Pool in Orthotopic Heart Transplantation
United States20 participantsStarted 2017-08-01
Plain-language 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).
Who can participate
Age range
18 Years – 71 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Amiodar…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.