Microvascular Cardiac Allograft Vasculopathy Trial

NCT ID: NCT05826444

Last Updated: 2024-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2025-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Cardiac Allograft Vasculopathy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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microvascular cardiac allograft vasculopathy

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

Echocardiography

Intervention Type DIAGNOSTIC_TEST

Echocardiography with afterload change

Magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

Stress-MRI

Magnetocardiography

Intervention Type DIAGNOSTIC_TEST

Magnetocardiography

Histology

Intervention Type DIAGNOSTIC_TEST

Histological analysis

Genetics

Intervention Type DIAGNOSTIC_TEST

miRNA sequencing

calcium signaling

Intervention Type DIAGNOSTIC_TEST

cardiomyocyte calcium signaling

IMR

Intervention Type DIAGNOSTIC_TEST

Index of microvascular resistance measurement

Angio-IMR

Intervention Type DIAGNOSTIC_TEST

Angiography derived post-processing index if microvascular resistance

control

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

Echocardiography

Intervention Type DIAGNOSTIC_TEST

Echocardiography with afterload change

Magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

Stress-MRI

Magnetocardiography

Intervention Type DIAGNOSTIC_TEST

Magnetocardiography

Histology

Intervention Type DIAGNOSTIC_TEST

Histological analysis

Genetics

Intervention Type DIAGNOSTIC_TEST

miRNA sequencing

calcium signaling

Intervention Type DIAGNOSTIC_TEST

cardiomyocyte calcium signaling

IMR

Intervention Type DIAGNOSTIC_TEST

Index of microvascular resistance measurement

Angio-IMR

Intervention Type DIAGNOSTIC_TEST

Angiography derived post-processing index if microvascular resistance

Interventions

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Echocardiography

Echocardiography with afterload change

Intervention Type DIAGNOSTIC_TEST

Magnetic resonance imaging

Stress-MRI

Intervention Type DIAGNOSTIC_TEST

Magnetocardiography

Magnetocardiography

Intervention Type DIAGNOSTIC_TEST

Histology

Histological analysis

Intervention Type DIAGNOSTIC_TEST

Genetics

miRNA sequencing

Intervention Type DIAGNOSTIC_TEST

calcium signaling

cardiomyocyte calcium signaling

Intervention Type DIAGNOSTIC_TEST

IMR

Index of microvascular resistance measurement

Intervention Type DIAGNOSTIC_TEST

Angio-IMR

Angiography derived post-processing index if microvascular resistance

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

OTHER

Sponsor Role collaborator

Deutsche Stiftung für Herzforschung

OTHER

Sponsor Role collaborator

German Heart Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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DHZC Deutsches Herzzentrum der Charité

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Facility Contacts

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Isabell Just, MD

Role: primary

00493045932025

Other Identifiers

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mCAV

Identifier Type: -

Identifier Source: org_study_id

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