Microvascular Cardiac Allograft Vasculopathy Trial
Morphological and Functional Phenotype of Isolated Microvascular Cardiac Allograft Vasculopathy in Heart Transplant Recipients
German Heart Institute
50 participants
Oct 1, 2022
OBSERVATIONAL
Conditions
Summary
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
Inclusion Criteria5
- 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
- Exercise tolerant in everyday life - cycling, climbing stairs at least 2 floors at a moderate speed without symptoms of exertion or dyspnea
Exclusion Criteria6
- 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
- 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
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Interventions
Echocardiography with afterload change
Stress-MRI
Magnetocardiography
Histological analysis
miRNA sequencing
cardiomyocyte calcium signaling
Index of microvascular resistance measurement
Angiography derived post-processing index if microvascular resistance
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05826444