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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Endocrine System Diseases; Thyroid Diseases; Diabetes Insipidus; End-stage Heart Failure; Cortisol Deficiency; End Stage Lung Disease
• Intervention / Treatment: Procedure: Blood test

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Hungary
  • Pest
    • Budapest, Pest, Hungary, 1122
      • Heart and Vascular Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergoing heart or lung transplation and their organ donors.

Description

Inclusion Criteria:

• Patients over 18 years of age admitted for heart or lung transplantation and their organ donors.
• written consent from the recipients

Exclusion Criteria:

• lack of consent
• non-evaluable patient due to insufficient clinical information

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Blood test; Patients will have a blood test to define hormone levels.	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.; Other Names: transplantation; explantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The composite of in-hospital death of any cause	In-hospital death of any cause	Patient will be followed during the hospital stay, an expected average of a month.
Endocrine changes and their correction in heart and lung tranplant recipients	Five year mortality rate	5 years
Endocrine changes and their correction in heart and lung tranplant donors	Number of successfully transplanted organs	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endocrine changes and their correction in heart tranplant recipients	The function of the transplanted heart	five years
Endocrine changes and their correction in lung tranplant recipients	The function of the transplanted lung	five years
Evidence of clinically definite postoperative complications	Complications occuring during five year after the transplantation	five years

Collaborators and Investigators

• Sponsor: Semmelweis University Heart and Vascular Center
• Collaborators: Semmelweis University
• Investigators: Study Director: Andrea dr. Székely, MD PhD, Semmelweis University; Principal Investigator: Ágnes dr. Sándor, MD, Semmeweis University; Principal Investigator: András dr. Szabó, MD, Semmelweis University

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2020
• Primary Completion (Anticipated): May 15, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (Actual): April 17, 2020

Study Record Updates

• Last Update Posted (Actual): January 24, 2022
• Last Update Submitted That Met QC Criteria: January 7, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: transplantation; endocrine
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Kidney Diseases; Urologic Diseases; Pituitary Diseases; Lung Diseases; Thyroid Diseases; Endocrine System Diseases; Diabetes Insipidus
• Other Study ID Numbers: VSZÉK TRANSPLANT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No