Microvascular Cardiac Allograft Vasculopathy Trial
ConditionCardiac Allograft Vasculopathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorGerman Heart Institute
About this trial
The aim of the mCAV study is a comprehensive characterization of the genetic, morphological and functional phenotype of isolated microvascular graft vasculopathy (mCAV) after orthotopic heart transplantation (OHT).
The utilized methods include dynamic echocardiography, magnetic resonance imaging, invasive microvascular resistance measurements, histology, cellular calcium-signaling and magnetocardiography as well as molecular genetic expression analysis (miRNA based).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
able to consent
Written consent of the participant after clarification and sufficient time to think about participation
heart transplant recipient
Indication for routine invasive diagnostics or due to symptoms
Disqualifiers
Addiction or other diseases that do not allow the patient to assess the nature and scope as well as possible consequences of the study
Patients or their legal guardians who do not sign the declaration of consent or who cannot fully understand it due to a lack of German language skills
Pregnant women, breastfeeding women
Severe comorbidities affecting the miRNA profile: diabetes mellitus, malignancy, end-stage renal disease with renal replacement therapy
Trial population
Heart transplant recipients
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Echocardiography
Diagnostic testEchocardiography with afterload change
Magnetic resonance imaging
Diagnostic testStress-MRI
Magnetocardiography
Diagnostic testMagnetocardiography
Histology
Diagnostic testHistological analysis
Genetics
Diagnostic testmiRNA sequencing
calcium signaling
Diagnostic testcardiomyocyte calcium signaling
IMR
Diagnostic testIndex of microvascular resistance measurement
Angio-IMR
Diagnostic testAngiography derived post-processing index if microvascular resistance
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: microvascular cardiac allograft vasculopathy8 interventions
Group B: control8 interventions
Trial outcomes
Primary outcomes
1
mCAV status influences pw-doppler wall motion analysis in echocardiography
pw-doppler wall motion analysis is measured with afterload increase
Time frame
at study inclusion2
mCAV status influences global longitudinal strain in echocardiography
global longitudinal strain is measured by speckle tracking analysis with afterload increase
Time frame
at study inclusion3
mCAV status influences diastolic strain in echocardiography
diastolic strain is measured by speckle tracking analysis with afterload increase
Time frame
at study inclusion4
mCAV status influences cardiac deformity
cardiac deformity analysis are performed by MRI
Time frame
at study inclusionSecondary outcomes
1
mCAV status influences the intrinsic cardiac magnetic field
the intrinsic cardiac magnetic field is measured by magnetocardiography
Time frame
at study inclusion2
mCAV status influences the cellular calcium signaling
the cellular calcium is visualized by confocal laser microscopy using electrical stimulation
Time frame
at study inclusion3
mCAV status influences subcellular structures
mitochondria, T-tubuli are described after visualization by confocal laser microscopy
Time frame
at study inclusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
German Heart Institute
Lead sponsor
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Collaborator
Deutsche Stiftung für Herzforschung
Collaborator
Source ClinicalTrials.gov