Noninvasive Methods to Monitor Graft Survival in Heart Transplant Patients

Heart Transplant Clinical Trial

Official title:

Observational Study of Alloimmunity in Cardiac Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00466804
• Other study ID #: DAIT CTOT-05
• Status: Completed
• Phase: N/A
• First received: April 25, 2007
• Last updated: December 31, 2015
• Start date: June 2007
• Est. completion date: July 2011

Study information

• Verified date: December 2015
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Data and Safety Monitoring BoardUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Injury of transplant tissue by a transplant recipient's immune system continues to be the leading cause of graft rejection and recipient death. The purpose of this study is to identify a single test or a combination of noninvasive tests currently used for heart transplant monitoring that correlate to long-term graft survival.

Description:

A major cause of heart transplant failure is the blockage of blood flow from lesions caused by ongoing injury and repair of the graft by the host's immune system. However, the role of T cells, antibodies, and other parts of the recipient's immune system are not well understood in transplant injury. Currently, there are no effective, noninvasive ways to detect or predict how an individual's immune system will react to a transplant. The purpose of this study is to correlate current noninvasive monitoring tests with long-term graft survival and function, and determine which tests are the most accurate predictors of this survival.

Participants in this study must currently be on the waiting list for a heart transplant and have a donor heart available to them. This study will consist of six study visits over 12 months. The baseline visit will occur on the day of transplantation. Follow-up visits will occur at Week 6 and Months 3, 6, 9, and 12 post-transplant. At each visit, a physical exam, medication tracking, assessment of graft survival, and blood and urine collection will occur. At the Week 6 and Month 12 visits, intravascular ultrasound and echocardiograms will occur. At the Week 6, Month 6, and Month 12 visits, endomyocardial biopsies will also occur. No immunosuppressive therapy will be provided by the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• Age greater than 10 and a body mass of 30 kg (66 lbs) or more

• On waiting list for a heart transplant for whom a donor heart available

• Willing to comply with study protocol

• Willing to use acceptable forms of contraception

• Parent or guardian willing to provide consent, if applicable

Exclusion Criteria:

• Receiving multiple organ transplants

• Previously received organ transplants

• Other comorbidities that, in the opinion of the site investigator, would interfere with the study

• Currently taking immunosuppression for nontransplant reasons

• Participation in an interventional clinical trial

• Pregnancy or breastfeeding

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Transplant

Intervention

Procedure:
• Heart transplant
People in this study will have a heart transplant and be monitored for signs of rejection

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Northwestern University Medical School	Chicago	Illinois
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Medical City Dallas Hospital	Dallas	Texas
United States	Loyola University School of Medicine	Maywood	Illinois
United States	Mount Sinai School of Medicine	New York	New York
United States	Beth Israel Medical Center	Newark	New Jersey
United States	University of Utah, LDS Hospital	Salt Lake City	Utah
United States	University of Utah, VACM.LDS	Salt Lake City	Utah
United States	University of California	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Clinical Trials in Organ Transplantation, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Jiang S, Lechler RI. CD4+CD25+ regulatory T-cell therapy for allergy, autoimmune disease and transplant rejection. Inflamm Allergy Drug Targets. 2006 Dec;5(4):239-42. Review. — View Citation

Starling RC, Pham M, Valantine H, Miller L, Eisen H, Rodriguez ER, Taylor DO, Yamani MH, Kobashigawa J, McCurry K, Marboe C, Mehra MR, Zuckerman A, Deng MC; Working Group on Molecular Testing in Cardiac Transplantation. Molecular testing in the management of cardiac transplant recipients: initial clinical experience. J Heart Lung Transplant. 2006 Dec;25(12):1389-95. Review. Erratum in: J Heart Lung Transplant. 2007 Feb;26(2):204. — View Citation

Starling RC, Stehlik J, Baran DA, Armstrong B, Stone JR, Ikle D, Morrison Y, Bridges ND, Putheti P, Strom TB, Bhasin M, Guleria I, Chandraker A, Sayegh M, Daly KP, Briscoe DM, Heeger PS; CTOT-05 consortium. Multicenter Analysis of Immune Biomarkers and He — View Citation

Zheng XX, Sánchez-Fueyo A, Sho M, Domenig C, Sayegh MH, Strom TB. Favorably tipping the balance between cytopathic and regulatory T cells to create transplantation tolerance. Immunity. 2003 Oct;19(4):503-14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Measure of Transplant Health	A composite of incidence of the following: Death,; Re-transplantation or re-listed for transplantation,; Biopsy proven acute rejection (BPAR) of > 2R,; Episode of rejection associated with hemodynamic compromise,; Coronary artery vasculopathy defined by a change in MIT of >0.5 mm between study entry and 12 months.	12 months after enrollment in study	Yes

External Links

•   Click here for the Clinical Trials in Organ Transplantation [CTOT] public Web site
•   National Institute of Allergy and Infectious Diseases (NIAID)