Clinical Trials

This is a safety study to compare the safety of receiving a lung treated with the Toronto EVLP System™ by SPONSOR in SPONSOR's dedicated facility against standard lung transplantation.

The purpose of this study is to evaluate the clinical performance of the Aptima CMV Quant assay on the Panther system in ethylenediaminetetraacetic acid (EDTA) plasma samples from solid organ transplantation recipients (SOTR) and hematopoietic stem cell transplant recipients (HSCTR).

The purpose of this study is to evaluate the safety and effectiveness of the Centralized Lung Evaluation System (CLES) in enabling evaluation of potential donor lungs not otherwise used for transplant into subjects with end stage, survival-limiting lung disease in need of lung transplantation. This will be accomplished by evaluating subject survival at the later of 6 months or hospital discharge post-transplant.

The purpose of this study is to:

• Demonstrate pharmacogenetic variability in the Mayo Clinic Florida lung transplant population.
• Describe patterns in tacrolimus levels in the context of pharmacogenomic profiles
• Use pharmacogenomic data to establish a need for therapeutic drug monitoring in selected other drugs
• Use pharmacogenomic data, in combination with knowledge of drug interactions, to establish sensitivity to tacrolimus dose changes

The purpose of this study is to determine if DNA originating from the transplanted heart or lung can be detected in the blood and used to monitor for rejection.

The purpose of this study is to longitudinally follow Torque Teno Virus (TTV) levels in lung transplant recipients and attempt to find a correlation with infection or rejection events.

The purpose of this study is to characterize esophageal function across a broad spectrum of pulmonary disease.

• By exploring whether mortality and allograft rejection (acute and chronic) differs in patients with gastroesophageal reflux (GER) from those without GER, following lung transplantation.
• By identifying specific patterns in the type/severity of GER (acid/non-acid, proximal/distal) and esophageal dysmotility (impaired reflux clearance, impaired bolus transit, decrease post-reflux swallow induced peristalsis) that will associate with respiratory function and symptoms; and in the transplant patients, post-transplant outcomes and chronic lung allograft dysfunction.

Ability to adhere to complex medical regimens is critical to achieving successful transplant outcomes, as non-adherent patients suffer graft failure and death following transplantation. Since potential recipients greatly exceed organ availability, identification of candidates who will adhere to complex post-transplant regimens is critically important and emphasized by practice guidelines. When selecting candidates for transplant, physicians try to subjectively predict post-transplant adherence because, although tools exist to measure current adherence, tools that reliably predict future adherence are lacking. Despite rigorous medical and psychosocial screening pretransplant, non-adherence rates are high following transplant. Therefore, the current approach for predicting future non-adherence is suboptimal, subjective, and greatly needs strategies for improvement.

Pre-transplant self-management abilities represent a marker of future adherence post-transplant. Assessing self-management as a means for predicting future adherence has been largely overlooked. Self-management is defined as "taking responsibility for one's own behavior and well-being" and consists of three management tasks: medical condition, emotions, and social roles. Self-management ability can be measured. However, self-management has not been systematically studied in heart and lung transplant patients. Fostering self-management abilities may improve post-transplant outcomes by optimizing not only adherence, but also proven pretransplant risk factors (e.g. frailty and obesity).Self-management abilities may be improved via behavioral interventions such as health coaching.Self-management represents a measurable criterion that could be utilized in pre-transplant screening and serve as a point of intervention for optimizing adherence and pre-transplant risk factors.The overall objective of the proposed research is to improve the knowledge gap regarding self-management (and thereby adherence) in transplant by qualitatively and quantitatively studying patient factors associated with self-management and testing an intervention that may improve self-management.

The investigators hypothesize: Individualized health coaching including strategies to address poor resilience, coping with uncertainty, frailty, and/or negative affect will be an effective therapeutic strategy at improving self-management while in the pre-transplant state.

Specific Aim: To test whether transplant candidates who receive pre transplant health coaching have greater improvement in self-management abilities.

The investigators will conduct a randomized, controlled pilot trial testing the effectiveness of health coaching versus usual care in a heart and lung transplant cohort on self-management abilities (SMAS-30).

To create a biorepository of fluid [lung lavage], blood and tissue specimens [explanted diseased lung tissue from the recipient and serial lung biopsy specimens after transplant] for future studies.

The purpose of this study is to collect lung tissue and blood samples from participants who undergo medically-indicated lung surgery and maintain a bank of specimens from a wide range of participants with varying types of lung disease and progressions.