Heart Transplant Failure and RejectionNCT03499197
Heart TIMING - Heart Transplantation IMagING
An observational study of Heart Transplant Failure and Rejection and Magnetic Resonance Imaging, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.
Trial summary
The cardiac allograft rejection (CAR) and cardiac allograft vasculopathy (CAV) significantly affect the prognosis of patients after heart transplantation. The aim of the present study is to investigate and differentiate the adaptive and pathological cardiovascular changes after heart transplantation using different… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Transplant Failure and Rejection, Magnetic Resonance Imaging
- What is being tested?
- cardiac magnetic resonance imaging
- How many people
- 100 participants
- Where
- 1 siteHungary
- Study dates
- 15 Jan 2018to 15 Jan 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent first cardiac transplantation.
Who may be able to join
- First heart transplantation
Who cannot join
- Cardiogenic shock on/after day 28 after heart transplantation
- Lack of consent
- Lack of cooperation
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
Heart and Vascular Center, Semmelweis University
Budapest
Hajnalka Vago, MD, PhD
About this study
Official title: Morphological and Functional Changes After Heart Transplantation - Role of Noninvasive Imaging in the Early Detection of Cardiac Allograft Rejection and Vasculopathy
The cardiac allograft rejection (CAR) and cardiac allograft vasculopathy (CAV) significantly affect the prognosis of patients after heart transplantation. The aim of the present study is to investigate and differentiate the adaptive and pathological cardiovascular changes after heart transplantation using different modalities. The investigator's main purpose is to define the role of the cardiovascular imaging methods and biomarkers in the early diagnosis of CAR and CAV.
Read the detailed description
- 12-lead ECG - Resting standard 12-lead digital ECG will be recorded. Extended analysis will be performed according to the latest recommendations.
- Holter ECG - 24 hour Holter ECG will be recorded. Extended Holter ECG analysis will be performed.
- Life quality questionnaire, patient history - Detailed questionnaire about personal and family history, general symptoms and life quality.
- Laboratory biochemical examination - Besides the regular routine laboratory parameters, several specific parameters are planned to be measured, such as cardiac biomarkers.
- Endomyocardial biopsy
- Detailed transthoracic echocardiography including strain analysis and 3D measurement
- Detailed cardiac magnetic resonance (CMR) examination
- Coronary imaging - invasive coronarography and intravascular ultrasound (IVUS) and/or optical coherence tomography (OCT)
- Invasive pressure measurement - Measurement of coronary flow reserve (CFR) and microcirculation resistance index (IMR)
- Being tested
- cardiac magnetic resonance imaging
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac magnetic resonance imagingDiagnostic test
Detailed and regular CMR examination (LGE, stress perfusion, T1, T2 mapping)
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary allograft vasculopathy
Coronary allograft vasculopathy confirmed based on IVUS/OCT
Measured: 5 years
Coronary allograft rejection
Coronary allograft rejection confirmed based on endomyocardial biopsy/clinical parameters
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 posted17 Apr 2018
- Study start15 Jan 2018
- Primary completion15 Jan 2021 (estimated)
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Transplant Failure and RejectionStudies 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)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Semmelweis University Heart and Vascular Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Research, Development and Innovation Office, Hungary
- Responsible party
- Principal investigator, Hajnalka Vágó MD PhD, Semmelweis University Heart and Vascular Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499197
- Sponsor's protocol ID
- Heart TIMING 001
- Status last verified
- Apr 2018
- First submitted
- 11 Apr 2018
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological and Functional Changes After Heart Transplantation - Role of Noninvasive Imaging in the Early Detection of Cardiac Allograft Rejection and Vasculopathy
- ClinicalTrials.gov ID
- NCT03499197
- Acronym / sponsor ID
- Heart TIMING 001
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Semmelweis University Heart and Vascular CenterUniversity, hospital or other
- Collaborators
- National Research, Development and Innovation Office, Hungary
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 15 Jan 2021 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 17 Apr 2018 (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 cardiac allograft rejection (CAR) and cardiac allograft vasculopathy (CAV) significantly affect the prognosis of patients after heart transplantation. The aim of the present study is to investigate and differentiate the adaptive and pathological cardiovascular changes after heart transplantation using different modalities. The investigator's main purpose is to define the role of the cardiovascular imaging methods and biomarkers in the early diagnosis of CAR and CAV.
Detailed description
- 12-lead ECG - Resting standard 12-lead digital ECG will be recorded. Extended analysis will be performed according to the latest recommendations.
- Holter ECG - 24 hour Holter ECG will be recorded. Extended Holter ECG analysis will be performed.
- Life quality questionnaire, patient history - Detailed questionnaire about personal and family history, general symptoms and life quality.
- Laboratory biochemical examination - Besides the regular routine laboratory parameters, several specific parameters are planned to be measured, such as cardiac biomarkers.
- Endomyocardial biopsy
- Detailed transthoracic echocardiography including strain analysis and 3D measurement
- Detailed cardiac magnetic resonance (CMR) examination
- Coronary imaging - invasive coronarography and intravascular ultrasound (IVUS) and/or optical coherence tomography (OCT)
- Invasive pressure measurement - Measurement of coronary flow reserve (CFR) and microcirculation resistance index (IMR)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent first cardiac transplantation.
Key inclusion criteria (1 listed)
- First heart transplantation
Key exclusion criteria (3 listed)
- Cardiogenic shock on/after day 28 after heart transplantation
- Lack of consent
- Lack of cooperation
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 |
|---|---|---|
| cardiac magnetic resonance imagingDetailed and regular CMR examination (LGE, stress perfusion, T1, T2 mapping) | Diagnostic test | – |
Primary outcome
Coronary allograft vasculopathy
Time frame: 5 years
Coronary allograft vasculopathy confirmed based on IVUS/OCT
Coronary allograft rejection
Time frame: 5 years
Coronary allograft rejection confirmed based on endomyocardial biopsy/clinical parameters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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.
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 Heart Transplant Failure and Rejection and Magnetic Resonance Imaging, 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 1 inclusion and 3 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 17 Apr 2018. 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?
Contact Hajnalka Vago, MD, PhD (+3620 8258058, vagoha@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary allograft vasculopathy (time frame: 5 years). The study lists 2 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 17 Apr 2018.