NCT05826444 Microvascular Cardiac Allograft Vasculopathy Trial
| NCT ID | NCT05826444 |
| Status | Recruiting |
| Phase | — |
| Sponsor | German Heart Institute |
| Condition | Cardiac Allograft Vasculopathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-10-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2022-10-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Frequently Asked Questions
Who can join the NCT05826444 clinical trial?
This trial is open to participants of all sexes, studying Cardiac Allograft Vasculopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05826444 currently recruiting?
Yes, NCT05826444 is actively recruiting participants. Visit ClinicalTrials.gov or contact German Heart Institute to inquire about joining.
Where is the NCT05826444 trial being conducted?
This trial is being conducted at Berlin, Germany.
Who is sponsoring the NCT05826444 clinical trial?
NCT05826444 is sponsored by German Heart Institute. The trial plans to enroll 50 participants.