NCT04351945

Endocrine Changes and Their Correction in Heart and Lung Transplant Recipients and Donors

A Study of Endocrine Changes and Their Correction in Heart and Lung Transplant Recipients and Donors

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Semmelweis University Heart and Vascular Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to assess the impact of endocrine changes and their correction on survival and organ function in heart and lung transplant recipients. This study also features an investigation of the hormone levels and hormonal replacement therapy of the donors to study its role in the function of the transplanted hearts and lungs. Thyroid hormones (TSH, thyroxine, tri-iodothyronine), cortisol and the antidiuretic hormone will be studied. The former two hormone levels will be defined in the recipients just before transplantation and three days later. In the case of the donors all three hormones will be recorded at the time of the explantation. The investigators would like to record the hormonal replacement therapy in all our patients as well to see it's effect on survival and on the transplanted organ function. After the transplantation during the hospital stays all the important hemodynamic parameters, laboratory parameters, the result of the medical imagings, the medication, the length of ICU and hospital stay and the complications were recorded. Recipients will be followed for five years. Organ function will be assessed every three month for a year, after than every six month for further four years. Investigator would like to record the result of the cardiac echocardiography, spirometries, imaging, and complications. Our purpose is to compare these results against the endocrine disorders and the replacement therapy.

Conditions

• Endocrine System Diseases
• Thyroid Diseases
• Cortisol Deficiency
• Diabetes Insipidus
• End-stage Heart Failure
• End Stage Lung Disease

Interventions

Type	Name	Description
PROCEDURE	Blood test	Hormone levels will be measured just before transplantation, and three day after the transplantation. In case of the donors hormone levels will be defined during the explantation.

Timeline

• Start date: 2020-05-20
• Primary completion: 2022-05-15
• Completion: 2022-07-01
• First posted: 2020-04-17
• Last updated: 2022-01-24

Locations

1 site across 1 country: Hungary