Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2022-10-01
2025-12-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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microvascular cardiac allograft vasculopathy
Heart transplant recipients with microvascular cardiac allograft vasculopathy defined by histopathology and invasive index of microvascular resistance.
Echocardiography
Echocardiography with afterload change
Magnetic resonance imaging
Stress-MRI
Magnetocardiography
Magnetocardiography
Histology
Histological analysis
Genetics
miRNA sequencing
calcium signaling
cardiomyocyte calcium signaling
IMR
Index of microvascular resistance measurement
Angio-IMR
Angiography derived post-processing index if microvascular resistance
control
Heart transplant recipients without microvascular cardiac allograft vasculopathy defined by histopathology and invasive index of microvascular resistance.
Echocardiography
Echocardiography with afterload change
Magnetic resonance imaging
Stress-MRI
Magnetocardiography
Magnetocardiography
Histology
Histological analysis
Genetics
miRNA sequencing
calcium signaling
cardiomyocyte calcium signaling
IMR
Index of microvascular resistance measurement
Angio-IMR
Angiography derived post-processing index if microvascular resistance
Interventions
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Echocardiography
Echocardiography with afterload change
Magnetic resonance imaging
Stress-MRI
Magnetocardiography
Magnetocardiography
Histology
Histological analysis
Genetics
miRNA sequencing
calcium signaling
cardiomyocyte calcium signaling
IMR
Index of microvascular resistance measurement
Angio-IMR
Angiography derived post-processing index if microvascular resistance
Eligibility Criteria
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Inclusion Criteria
* 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
* Exercise tolerant in everyday life - cycling, climbing stairs at least 2 floors at a moderate speed without symptoms of exertion or dyspnea
Exclusion Criteria
* 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
* Contraindication to the stress test: signs of cardiac decompensation, angina pectoris, dyspnea, hyperthyroidism, GFR \<30 ml/min, peripheral arterial disease, pheochromocytoma, angle-closure glaucoma, prostate adenoma, paroxysmal tachycardia, tachycardia atrial fibrillation
* Evidence of an acute rejection or local wall motion disturbances in the resting echocardiography
ALL
No
Sponsors
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Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
OTHER
Deutsche Stiftung für Herzforschung
OTHER
German Heart Institute
OTHER
Responsible Party
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Locations
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DHZC Deutsches Herzzentrum der Charité
Berlin, , Germany
Countries
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Facility Contacts
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Other Identifiers
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mCAV
Identifier Type: -
Identifier Source: org_study_id
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