Clinical trial NCT05826444: Microvascular Cardiac Allograft Vasculopathy Trial
Official title: Morphological and Functional Phenotype of Isolated Microvascular Cardiac Allograft Vasculopathy in Heart Transplant Recipients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Allograft Vasculopathy
Keywords: heart transplantation
cardiac allograft vasculopathy
Lead sponsor: German Heart Institute
Sponsor class: OTHER
Collaborators: name: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
name: Deutsche Stiftung für Herzforschung
First posted: 2023-04-24
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Heart transplant recipients

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

Primary outcomes:
measure: mCAV status influences pw-doppler wall motion analysis in echocardiography
timeFrame: at study inclusion
measure: mCAV status influences global longitudinal strain in echocardiography
timeFrame: at study inclusion
measure: mCAV status influences diastolic strain in echocardiography
timeFrame: at study inclusion
measure: mCAV status influences cardiac deformity
timeFrame: at study inclusion
measure: mCAV status influences grade of fibrosis
timeFrame: at study inclusion
measure: mCAV status influences extracellular volume
timeFrame: at study inclusion
measure: mCAV status influences the circulating miRNA profile
timeFrame: at study inclusion
Secondary outcomes:
measure: mCAV status influences the intrinsic cardiac magnetic field
timeFrame: at study inclusion
measure: mCAV status influences the cellular calcium signaling
timeFrame: at study inclusion
measure: mCAV status influences subcellular structures
timeFrame: at study inclusion
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: DHZC Deutsches Herzzentrum der Charité
Study officials:
References: