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Heart TIMING - Heart Transplantation IMagING

Morphological and Functional Changes After Heart Transplantation - Role of Noninvasive Imaging in the Early Detection of Cardiac Allograft Rejection and Vasculopathy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03499197
Enrollment
100
Registered
2018-04-17
Start date
2018-01-15
Completion date
2026-01-15
Last updated
2018-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Transplant Failure and Rejection, Magnetic Resonance Imaging

Brief 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 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

1. 12-lead ECG - Resting standard 12-lead digital ECG will be recorded. Extended analysis will be performed according to the latest recommendations. 2. Holter ECG - 24 hour Holter ECG will be recorded. Extended Holter ECG analysis will be performed. 3. Life quality questionnaire, patient history - Detailed questionnaire about personal and family history, general symptoms and life quality. 4. Laboratory biochemical examination - Besides the regular routine laboratory parameters, several specific parameters are planned to be measured, such as cardiac biomarkers. 5. Endomyocardial biopsy 6. Detailed transthoracic echocardiography including strain analysis and 3D measurement 7. Detailed cardiac magnetic resonance (CMR) examination 8. Coronary imaging - invasive coronarography and intravascular ultrasound (IVUS) and/or optical coherence tomography (OCT) 9. Invasive pressure measurement - Measurement of coronary flow reserve (CFR) and microcirculation resistance index (IMR)

Interventions

DIAGNOSTIC_TESTcardiac magnetic resonance imaging

Detailed and regular CMR examination (LGE, stress perfusion, T1, T2 mapping)

Sponsors

National Research, Development and Innovation Fund of Hungary, Project no. NVKP_16-1-2016-0017
CollaboratorUNKNOWN
Semmelweis University Heart and Vascular Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* First heart transplantation

Exclusion criteria

* Cardiogenic shock on/after day 28 after heart transplantation * Lack of consent * Lack of cooperation

Design outcomes

Primary

MeasureTime frameDescription
Coronary allograft vasculopathy5 yearsCoronary allograft vasculopathy confirmed based on IVUS/OCT
Coronary allograft rejection5 yearsCoronary allograft rejection confirmed based on endomyocardial biopsy/clinical parameters

Countries

Hungary

Contacts

Primary ContactHajnalka Vago, MD, PhD
vagoha@gmail.com+3620 8258058

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026