Microvascular Cardiac Allograft Vasculopathy Trial (mCAV)

German Heart Institute

Status: Enrolling

Conditions: Cardiac Allograft Vasculopathy

Treatments: Diagnostic Test: Magnetocardiography; Diagnostic Test: Histology; Diagnostic Test: calcium signaling; Diagnostic Test: Echocardiography; Diagnostic Test: Genetics; Diagnostic Test: Angio-IMR; Diagnostic Test: IMR; Diagnostic Test: Magnetic resonance imaging

Study type: Observational

Funder types: Other

Identifiers

NCT05826444

mCAV

Details and patient eligibility

About

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).

Enrollment: 50 estimated patients

Sex: All

Volunteers: No 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

Trial design

50 participants in 2 patient groups

microvascular cardiac allograft vasculopathy

Description:

Heart transplant recipients with microvascular cardiac allograft vasculopathy defined by histopathology and invasive index of microvascular resistance.

Treatment:

Diagnostic Test: Magnetic resonance imaging

Diagnostic Test: Angio-IMR

Diagnostic Test: IMR

Diagnostic Test: Genetics

Diagnostic Test: Echocardiography

Diagnostic Test: calcium signaling

Diagnostic Test: Histology

Diagnostic Test: Magnetocardiography

control

Description:

Heart transplant recipients without microvascular cardiac allograft vasculopathy defined by histopathology and invasive index of microvascular resistance.

Treatment:

Diagnostic Test: Magnetic resonance imaging

Diagnostic Test: Angio-IMR

Diagnostic Test: IMR

Diagnostic Test: Genetics

Diagnostic Test: Echocardiography

Diagnostic Test: calcium signaling

Diagnostic Test: Histology

Diagnostic Test: Magnetocardiography