HCV Positive Heart Donors | NCT03382847

NCT03382847

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention arm	Experimental	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.	Combination Product: Transplant with HCV positive donor, followed by surveillance and treatment of viremia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transplant with HCV positive donor, followed by surveillance and treatment of viremia	Combination Product	Heart transplant with HCV positive donor, followed by treatment for viremia if viremia occurs

Outcomes Module

Measure	Description	Time Frame
Sustained Virologic Response After Treatment	Percentage of patients with sustained virologic response after treatment for HCV after heart transplant.	1 year

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Alex Reyentovich, MD	NYU Langone Health	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
NYU Langone Transplant Institute		New York	New York	10016	United States

IPD Sharing Statement Module

Arm/Group Information

ID	Title	Description
FG000	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

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Sustained Virologic Response After Treatment

Percentage of patients with sustained virologic response after treatment for HCV after heart transplant.

100% of surviving patients met this endpoint. One patient expired in the early post-operative period.

Posted

Count of Participants

Participants

1 year

ID	Title	Description
OG000	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

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
pancreatitis	Hepatobiliary disorders		Systematic Assessment

More Info Module

Certain Agreements

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 28, 2018	Jan 14, 2021	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Aug 28, 2018	Jan 14, 2021	SAP_001.pdf

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases