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Microvascular Cardiac Allograft Vasculopathy Trial | Clinical Trials | Clareo Health

RECRUITING

Microvascular Cardiac Allograft Vasculopathy Trial

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

NCT05826444•German Heart Institute

View on ClinicalTrials.gov

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

Age

All ages

Sex

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

Locations (1)

DHZC Deutsches Herzzentrum der Charité

Berlin, Germany

Key Dates

Start Date

October 1, 2022

Primary Completion Date

December 31, 2025

Completion Date

December 31, 2025

Last Updated

August 12, 2024

Enrollment

ESTIMATED participants

Conditions

Cardiac Allograft Vasculopathy

Interventions

Echocardiography

DIAGNOSTIC_TEST

Magnetic resonance imaging

DIAGNOSTIC_TEST

Magnetocardiography

DIAGNOSTIC_TEST

Histology

DIAGNOSTIC_TEST

Genetics

DIAGNOSTIC_TEST

calcium signaling

DIAGNOSTIC_TEST

IMR

DIAGNOSTIC_TEST

Angio-IMR

DIAGNOSTIC_TEST

Determining the Association of Microvascular Disease as Assessed by PET and Graft Injury by Donor Derived Cell Free DNA

NCT05756088

Cardiac Allograft VasculopathyEndothelial Dysfunction+1 more

View study

COMPLETED

Potential Role of Donor-derived Cell-Free DNA as a Biomarker in Cardiac Allograft Vasculopathy

NCT04791852

Cardiac Allograft Vasculopathy

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Microvascular Cardiac Allograft Vasculopathy Trial

Inclusion Criteria

Exclusion Criteria

Determining the Association of Microvascular Disease as Assessed by PET and Graft Injury by Donor Derived Cell Free DNA

Potential Role of Donor-derived Cell-Free DNA as a Biomarker in Cardiac Allograft Vasculopathy

Heart Failure After Heart Transplantation Due to Chronic Rejection

Endothelial Injury and Development of Coronary Intimal Thickening After Heart Transplantation

Optical Coherence Tomography (OCT) to Evaluate Cardiac Allograft Vasculopathy (CAV) in Patient's Post Heart Transplant

Clinical Trial of Pioglitazone for Prevention of Cardiac Allograft Vasculopathy After Heart Transplantation