Endocrine System DiseasesNCT04351945
Endocrine Changes and Their Correction in Heart and Lung Transplant Recipients and Donors
An observational study of Endocrine System Diseases and Thyroid Diseases, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endocrine System Diseases, Thyroid Diseases, Cortisol Deficiency
- What is being tested?
- Blood test
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteHungary
- Study dates
- 20 May 2020to 1 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing heart or lung transplation and their organ donors.
Who may be able to join
- Patients over 18 years of age admitted for heart or lung transplantation and their organ donors.
- written consent from the recipients
Who cannot join
- lack of consent
- non-evaluable patient due to insufficient clinical information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Blood test
- Keywords
- transplantation, endocrine
- Medical subject headings
- Endocrine System Diseases, Thyroid Diseases, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testProcedure or surgery
Also called transplantation, explantation
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.
| Study group | Role | What they receive |
|---|---|---|
| Blood test | Patients will have a blood test to define hormone levels. Receives: Procedure: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite of in-hospital death of any cause
In-hospital death of any cause
Measured: 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
Measured: 5 years
Endocrine changes and their correction in heart and lung tranplant donors
Number of successfully transplanted organs
Measured: one month
Secondary outcomes (3)
Endocrine changes and their correction in heart tranplant recipients
The function of the transplanted heart
Measured: five years
Endocrine changes and their correction in lung tranplant recipients
The function of the transplanted lung
Measured: five years
Evidence of clinically definite postoperative complications
Complications occuring during five year after the transplantation
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start20 May 2020
- Primary completion15 May 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocrine System DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University Heart and Vascular Center
- Sponsor type
- University, hospital or other
- Collaborators
- Semmelweis University
- Responsible party
- Principal investigator, Andrea Szekely, Semmelweis University Heart and Vascular Center
- Investigators
- Andrea dr. Székely, MD PhD, Study director, Semmelweis UniversityÁgnes dr. Sándor, MD, Principal investigator, Semmeweis UniversityAndrás dr. Szabó, MD, Principal investigator, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351945
- Sponsor's protocol ID
- VSZÉK TRANSPLANT
- Status last verified
- Jan 2022
- First submitted
- 15 Apr 2020
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Endocrine Changes and Their Correction in Heart and Lung Transplant Recipients and Donors
- ClinicalTrials.gov ID
- NCT04351945
- Acronym / sponsor ID
- VSZÉK TRANSPLANT
- Conditions
- Endocrine System Diseases, Thyroid Diseases, Cortisol Deficiency, Diabetes Insipidus, End-stage Heart Failure, End Stage Lung Disease
- Keywords
- transplantation, endocrine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Semmelweis University Heart and Vascular CenterUniversity, hospital or other
- Collaborators
- Semmelweis University
- Study start
- 20 May 2020 (actual)
- Primary completion
- 15 May 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood test | – | Procedure: Blood testPatients will have a blood test to define hormone levels. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing heart or lung transplation and their organ donors.
Key inclusion criteria (2 listed)
- Patients over 18 years of age admitted for heart or lung transplantation and their organ donors.
- written consent from the recipients
Key exclusion criteria (2 listed)
- lack of consent
- non-evaluable patient due to insufficient clinical information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testAlso: transplantation, explantationHormone 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. | Procedure or surgery | Blood test |
Primary outcome
The composite of in-hospital death of any cause
Time frame: Patient will be followed during the hospital stay, an expected average of a month.
In-hospital death of any cause
Endocrine changes and their correction in heart and lung tranplant recipients
Time frame: 5 years
Five year mortality rate
Endocrine changes and their correction in heart and lung tranplant donors
Time frame: one month
Number of successfully transplanted organs
3 secondary outcomes
Endocrine changes and their correction in heart tranplant recipients
Time frame: five years
Endocrine changes and their correction in lung tranplant recipients
Time frame: five years
Evidence of clinically definite postoperative complications
Time frame: five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea dr. Székely, MD PhD study director
Semmelweis University
Ágnes dr. Sándor, MD principal investigator
Semmeweis University
András dr. Szabó, MD principal investigator
Semmelweis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endocrine System Diseases and Thyroid Diseases, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The composite of in-hospital death of any cause (time frame: Patient will be followed during the hospital stay, an expected average of a month.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.