Characterizing microvascular graft vasculopathy in heart transplant recipients
Morphological and Functional Phenotype of Isolated Microvascular Cardiac Allograft Vasculopathy in Heart Transplant Recipients
This study looks at how small blood vessel problems affect heart transplant patients to better understand their condition and improve their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Sex | All |
| Sponsor | German Heart Institute Academic / other |
| Locations | 1 site (Berlin) |
| Trial ID | NCT05826444 on ClinicalTrials.gov |
What this trial studies
This observational study aims to comprehensively characterize the genetic, morphological, and functional phenotype of isolated microvascular graft vasculopathy (mCAV) in patients who have undergone orthotopic heart transplantation. The study employs various methodologies including dynamic echocardiography, magnetic resonance imaging, invasive microvascular resistance measurements, histology, cellular calcium-signaling, and molecular genetic expression analysis. By analyzing these factors, the study seeks to enhance understanding of mCAV and its implications for heart transplant recipients.
Who should consider this trial
Good fit: Ideal candidates for this study are heart transplant recipients who are able to provide informed consent and are exercise tolerant in everyday life.
Not a fit: Patients with severe comorbidities affecting the miRNA profile or those unable to understand the consent process due to language barriers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and therapeutic strategies for managing cardiac allograft vasculopathy in heart transplant patients.
How similar studies have performed: While this study focuses on a specific aspect of cardiac allograft vasculopathy, similar approaches in characterizing transplant-related complications have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Berlin
- DHZC Deutsches Herzzentrum der Charité — Berlin, Germany (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.