Microvascular Cardiac Allograft Vasculopathy Trial

Launched by GERMAN HEART INSTITUTE · Apr 12, 2023

Keywords

ClinConnect Summary

The Microvascular Cardiac Allograft Vasculopathy Trial is studying a condition called microvascular graft vasculopathy (mCAV) that can occur after a heart transplant. The goal of this research is to better understand the genetic and functional aspects of mCAV. Researchers will use various methods, such as advanced imaging techniques and other tests, to gather information about the condition. This study is currently recruiting participants who have received a heart transplant and are able to exercise without significant symptoms.

To be eligible, participants must be able to understand and consent to the study, and they should be heart transplant recipients showing signs that require further medical investigation. Importantly, they should be able to engage in physical activities like cycling or climbing stairs without experiencing serious issues like shortness of breath. Those with certain severe health conditions, pregnant or breastfeeding women, and individuals who cannot understand the study details due to language barriers are not eligible to participate. If you join the trial, you can expect a comprehensive evaluation of your heart health with the potential for improving future treatments for mCAV.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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