Disorder Related to Cardiac TransplantationNCT02347371
Heart Transplant Registry of Városmajor
An observational study of Disorder Related to Cardiac Transplantation, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.
Trial summary
The purpose of this registry is to determine the long term outcomes of heart transplantations performed at the Semmelweis University Heart and Vascular Center. All eventual interventional and non-interventional procedures will be accounted for and summarized. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Disorder Related to Cardiac Transplantation
- How many people
- 11 participants
- Where
- 1 siteHungary
- Study dates
- Jan 2015to May 2020
- How long will I take part?
- 5 Years
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart transplant recipient, cared for by the Semmelweis University Heart and Vascular Center
Who may be able to join
- Heart transplant recipient
- >18 years old
- Signed informed consent
- Cared for at the Semmelweis University Heart and Vascular Center
Who cannot join
- Denies consent to registry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follow-up Registry of Heart Transplant Recipients, to Determine Long Term Outcome and Need for Further Interventional and Non-interventional Procedures
The purpose of this registry is to determine the long term outcomes of heart transplantations performed at the Semmelweis University Heart and Vascular Center. All eventual interventional and non-interventional procedures will be accounted for and summarized.
- Keywords
- Heart transplant, Cardiac allograft vasculopathy, Chronic rejection, Immunosuppressant therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome of heart transplantation as measured by all-cause mortality
All-cause mortality will be assessed after transplantation in all participating subjects.
Measured: 5 years
Secondary outcomes (1)
Morbidity after heart transplantation
All invasive procedures that are required after initial surgery will be tracked and accounted for.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionMay 2020
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder Related to Cardiac TransplantationStudies 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
- 11 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Semmelweis University Heart and Vascular Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Béla Merkely, MD PhD DSc, Principal investigator, Semmelweis University Heart and Vascular Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347371
- Sponsor's protocol ID
- VSZR - 001
- Status last verified
- Apr 2021
- First submitted
- 15 Jan 2015
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Registry of Heart Transplant Recipients, to Determine Long Term Outcome and Need for Further Interventional and Non-interventional Procedures
- ClinicalTrials.gov ID
- NCT02347371
- Acronym / sponsor ID
- VSZR - 001
- Keywords
- Heart transplant, Cardiac allograft vasculopathy, Chronic rejection, Immunosuppressant therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Semmelweis University Heart and Vascular CenterUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- May 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 27 Jan 2015 (estimated)
- 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 purpose of this registry is to determine the long term outcomes of heart transplantations performed at the Semmelweis University Heart and Vascular Center. All eventual interventional and non-interventional procedures will be accounted for and summarized.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart transplant recipient, cared for by the Semmelweis University Heart and Vascular Center
Key inclusion criteria (4 listed)
- Heart transplant recipient
- >18 years old
- Signed informed consent
- Cared for at the Semmelweis University Heart and Vascular Center
Key exclusion criteria (1 listed)
- Denies consent to registry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Outcome of heart transplantation as measured by all-cause mortality
Time frame: 5 years
All-cause mortality will be assessed after transplantation in all participating subjects.
1 secondary outcome
Morbidity after heart transplantation
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
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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.
Béla Merkely, MD PhD DSc principal investigator
Semmelweis University Heart and Vascular Center
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 Disorder Related to Cardiac Transplantation, 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 23 Apr 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Outcome of heart transplantation as measured by all-cause mortality (time frame: 5 years). 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 23 Apr 2021.