Microvascular Cardiac Allograft Vasculopathy Trial

Morphological and Functional Phenotype of Isolated Microvascular Cardiac Allograft Vasculopathy in Heart Transplant Recipients

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05826444

Acronym

mCAV

Enrollment

Registered

2023-04-24

Start date

2022-10-01

Completion date

2025-12-31

Last updated

2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Allograft Vasculopathy

Keywords

heart transplantation, cardiac allograft vasculopathy

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).

Interventions

DIAGNOSTIC_TESTEchocardiography

Echocardiography with afterload change

DIAGNOSTIC_TESTMagnetic resonance imaging

Stress-MRI

DIAGNOSTIC_TESTMagnetocardiography

Magnetocardiography

DIAGNOSTIC_TESTHistology

Histological analysis

DIAGNOSTIC_TESTGenetics

miRNA sequencing

DIAGNOSTIC_TESTcalcium signaling

cardiomyocyte calcium signaling

DIAGNOSTIC_TESTIMR

Index of microvascular resistance measurement

DIAGNOSTIC_TESTAngio-IMR

Angiography derived post-processing index if microvascular resistance

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
mCAV status influences the circulating miRNA profile	at study inclusion	circulating miRNA profile is measured by miRNAseq
mCAV status influences cardiac deformity	at study inclusion	cardiac deformity analysis are performed by MRI
mCAV status influences grade of fibrosis	at study inclusion	fibrosis grades are measured by MRI
mCAV status influences extracellular volume	at study inclusion	extracellular volume is measured by MRI
mCAV status influences pw-doppler wall motion analysis in echocardiography	at study inclusion	pw-doppler wall motion analysis is measured with afterload increase
mCAV status influences global longitudinal strain in echocardiography	at study inclusion	global longitudinal strain is measured by speckle tracking analysis with afterload increase
mCAV status influences diastolic strain in echocardiography	at study inclusion	diastolic strain is measured by speckle tracking analysis with afterload increase

Secondary

Measure	Time frame	Description
mCAV status influences the cellular calcium signaling	at study inclusion	the cellular calcium is visualized by confocal laser microscopy using electrical stimulation
mCAV status influences subcellular structures	at study inclusion	mitochondria, T-tubuli are described after visualization by confocal laser microscopy
mCAV status influences the intrinsic cardiac magnetic field	at study inclusion	the intrinsic cardiac magnetic field is measured by magnetocardiography

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026