ClinicalTrials.Veeva

Menu

Heart TIMING - Heart Transplantation IMagING

S

Semmelweis University

Status

Enrolling

Conditions

Heart Transplant Failure and Rejection
Magnetic Resonance Imaging

Treatments

Diagnostic Test: cardiac magnetic resonance imaging

Study type

Observational

Funder types

Other

Identifiers

NCT03499197
Heart TIMING 001

Details and patient eligibility

About

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.

Full 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)

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • First heart transplantation

Exclusion criteria

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

Trial contacts and locations

1

Loading...

Central trial contact

Hajnalka Vago, MD, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems