Heart Failure
Conditions
Brief summary
Study subjects active on the waiting list for a heart transplant at the NYU Langone Transplant Institute who are hepatitis C (HCV) negative will receive a heart transplant from a donor who tests positive for HCV. The study will entail surveillance for the development of HCV viremia post-transplant. Patients who develop HCV viremia post-transplant will be treated with an FDA-approved, pan-genotypic direct acting antiviral drug, Mavyret. Patients who are treated with Mavyret will be monitored for clearance of viremia and for sustained virologic response.
Interventions
COMBINATION_PRODUCTTransplant with HCV positive donor, followed by surveillance and treatment of viremia
Heart transplant with HCV positive donor, followed by treatment for viremia if viremia occurs
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Listed for an isolated heart transplant at NYU Langone Health * Able to travel to the NYU Langone Health for routine post-transplant visits and study visits for a minimum of 6 months after transplantation * No active illicit substance abuse * Weight at least 50kg * Women of childbearing potential must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) after transplant due to the increased risk of birth defects and/or miscarriage * Both men and women must agree to use at least one barrier method after transplant to prevent any secretion exchange * Able and willing to provide informed consent
Exclusion criteria
* HIV positive * HCV RNA positive or history of previously treated HCV * Hepatitis B surface antigen positive or on active antiviral treatment for HBV * Pregnant or nursing (lactating) women * Use of strong CYP3A inducers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Virologic Response After Treatment | 1 year | Percentage of patients with sustained virologic response after treatment for HCV after heart transplant. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Arm HCV negative patients will receive a heart transplant from a HCV positive donor. Post-transplant, there will be surveillance for the development of viremia, and treatment of viremia. Following treatment, there will be surveillance for a sustained virologic response to HCV treatment.
Transplant with HCV positive donor, followed by surveillance and treatment of viremia: Heart transplant with HCV positive donor, followed by treatment for viremia if viremia occurs | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Intervention Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 57 years STANDARD_DEVIATION 12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 25 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 1 / 25 |
Outcome results
Primary
Sustained Virologic Response After Treatment
Percentage of patients with sustained virologic response after treatment for HCV after heart transplant.
Time frame: 1 year
Population: 100% of surviving patients met this endpoint. One patient expired in the early post-operative period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Sustained Virologic Response After Treatment | 24 Participants |