Noninvasive Methods to Monitor Graft Survival in Heart Transplant Patients

Status Completed

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.

Clinical Trial 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. ;

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Heart Transplant

Clinical Trial Details

NCT number	NCT00466804
Study type	Observational
Source	National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status	Completed
Phase	N/A
Start date	June 2007
Completion date	July 2011

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02964026` - Study of Clinical Outcomes Associated With the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients	N/A
Active, not recruiting	`NCT05096299` - OCS Heart EXPAND + CAP Continued Follow-Up
Completed	`NCT02323321` - International EXPAND Heart Pivotal Trial	N/A
Recruiting	`NCT05933083` - MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation	N/A
Completed	`NCT03150095` - Health Coaching to Improve Self-Management in Thoracic Transplant Candidates	N/A
Active, not recruiting	`NCT02554578` - Impact of mHealth in Heart Transplant Management	N/A
Terminated	`NCT03346278` - Text Message Intervention to Improve Cardiac Rehab Participation	N/A
Active, not recruiting	`NCT05741723` - OCS DCD Heart + CAP Continued Follow-Up
Completed	`NCT03831048` - Donors After Circulatory Death Heart Trial	N/A
Completed	`NCT04615182` - Donor After Circulatory Death Heart CAP Trial	N/A
Completed	`NCT02597543` - Stress Cardiac MRI for Evaluation of Nonspecific Allograft Dysfunction	Phase 4
Recruiting	`NCT05824364` - Exercise aNd hEArt Transplant	N/A
Not yet recruiting	`NCT05025774` - Fitness and Lung Function Among Survivors of Heart Transplant, Leukemia and Infant BPD Through Exercise
Enrolling by invitation	`NCT05390411` - Seeking Objectivity in Allocation of Advanced Heart Failure (SOCIAL HF) Therapies Trial	N/A
Recruiting	`NCT04770012` - AERIAL Trial: Antiplatelet Therapy in Heart Transplantation	Phase 3
Terminated	`NCT01769443` - Safety and Efficacy of Desensitization Therapy in Sensitized Participants Awaiting Heart Transplantation	Phase 2
Not yet recruiting	`NCT05459181` - HeartCare Immuno-optimization in Cardiac Allografts (MOSAIC)	N/A
Terminated	`NCT01485757` - Prospective L-arginine Study	Phase 1
Active, not recruiting	`NCT01186250` - Clinical Trial of Pioglitazone for Prevention of Cardiac Allograft Vasculopathy After Heart Transplantation	Phase 2
Completed	`NCT00812786` - Pharmacokinetics of Immunosuppressive Drugs in Heart Transplant Patients	Phase 4