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

Sponsor
Semmelweis University Heart and Vascular Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04351945
Collaborator
Semmelweis University (Other)
100
1
25.4
3.9

Study Details

Study Description

Brief 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Study of Endocrine Changes and Their Correction in Heart and Lung Transplant Recipients and Donors
Actual Study Start Date :
May 20, 2020
Anticipated Primary Completion Date :
May 15, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. The composite of in-hospital death of any cause [Patient will be followed during the hospital stay, an expected average of a month.]

      In-hospital death of any cause

    2. Endocrine changes and their correction in heart and lung tranplant recipients [5 years]

      Five year mortality rate

    3. Endocrine changes and their correction in heart and lung tranplant donors [one month]

      Number of successfully transplanted organs

    Secondary Outcome Measures

    1. Endocrine changes and their correction in heart tranplant recipients [five years]

      The function of the transplanted heart

    2. Endocrine changes and their correction in lung tranplant recipients [five years]

      The function of the transplanted lung

    3. Evidence of clinically definite postoperative complications [five years]

      Complications occuring during five year after the transplantation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Heart and Vascular Center Budapest Pest Hungary 1122

    Sponsors and Collaborators

    • Semmelweis University Heart and Vascular Center
    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrea Szekely, professor, Semmelweis University Heart and Vascular Center
    ClinicalTrials.gov Identifier:
    NCT04351945
    Other Study ID Numbers:
    • VSZÉK TRANSPLANT
    First Posted:
    Apr 17, 2020
    Last Update Posted:
    Jan 24, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Andrea Szekely, professor, Semmelweis University Heart and Vascular Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 24, 2022