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NCT Number: NCT05826444

Microvascular Cardiac Allograft Vasculopathy Trial

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).

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

DHZC Deutsches Herzzentrum der Charité

Berlin, 13353, Germany

Location status: Recruiting

Location contact

Isabell Just, MD

CONTACT

[email protected]

00493045932025

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echocardiography

Diagnostic Test

Echocardiography with afterload change

Magnetic Resonance Imaging

Diagnostic Test

Stress-MRI

Magnetocardiography

Diagnostic Test

Magnetocardiography

Histology

Diagnostic Test

Histological analysis

Genetics

Diagnostic Test

miRNA sequencing

calcium signaling

Diagnostic Test

cardiomyocyte calcium signaling

IMR

Diagnostic Test

Index of microvascular resistance measurement

Angio-IMR

Diagnostic Test

Angiography derived post-processing index if microvascular resistance

Primary outcomes

  1. mCAV status influences pw-doppler wall motion analysis in echocardiography

    Time frame: at study inclusion

    pw-doppler wall motion analysis is measured with afterload increase

  2. mCAV status influences global longitudinal strain in echocardiography

    Time frame: at study inclusion

    global longitudinal strain is measured by speckle tracking analysis with afterload increase

  3. mCAV status influences diastolic strain in echocardiography

    Time frame: at study inclusion

    diastolic strain is measured by speckle tracking analysis with afterload increase

  4. mCAV status influences cardiac deformity

    Time frame: at study inclusion

    cardiac deformity analysis are performed by MRI

  5. mCAV status influences grade of fibrosis

    Time frame: at study inclusion

    fibrosis grades are measured by MRI

  6. mCAV status influences extracellular volume

    Time frame: at study inclusion

    extracellular volume is measured by MRI

  7. mCAV status influences the circulating miRNA profile

    Time frame: at study inclusion

    circulating miRNA profile is measured by miRNAseq

Secondary outcomes

  1. mCAV status influences the intrinsic cardiac magnetic field

    Time frame: at study inclusion

    the intrinsic cardiac magnetic field is measured by magnetocardiography

  2. mCAV status influences the cellular calcium signaling

    Time frame: at study inclusion

    the cellular calcium is visualized by confocal laser microscopy using electrical stimulation

  3. mCAV status influences subcellular structures

    Time frame: at study inclusion

    mitochondria, T-tubuli are described after visualization by confocal laser microscopy

Sponsors and collaborators

Lead sponsor

German Heart Institute

Other

Collaborators

  • Deutsche Stiftung für Herzforschung
  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Registry information

Official study title

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

Acronym: mCAV

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 24, 2023
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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