Microvascular Cardiac Allograft Vasculopathy Trial (mCAV)

August 8, 2024 updated by: German Heart Institute

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Heart transplant recipients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
microvascular cardiac allograft vasculopathy
Heart transplant recipients with microvascular cardiac allograft vasculopathy defined by histopathology and invasive index of microvascular resistance.
Diagnostic test: Echocardiography
Echocardiography with afterload change
Diagnostic test: Magnetic resonance imaging
Stress-MRI
Diagnostic test: Magnetocardiography
Magnetocardiography
Diagnostic test: Histology
Histological analysis
Diagnostic test: Genetics
miRNA sequencing
Diagnostic test: calcium signaling
cardiomyocyte calcium signaling
Diagnostic test: IMR
Index of microvascular resistance measurement
Diagnostic test: Angio-IMR
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.
Diagnostic test: Echocardiography
Echocardiography with afterload change
Diagnostic test: Magnetic resonance imaging
Stress-MRI
Diagnostic test: Magnetocardiography
Magnetocardiography
Diagnostic test: Histology
Histological analysis
Diagnostic test: Genetics
miRNA sequencing
Diagnostic test: calcium signaling
cardiomyocyte calcium signaling
Diagnostic test: IMR
Index of microvascular resistance measurement
Diagnostic test: Angio-IMR
Angiography derived post-processing index if microvascular resistance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at study inclusion
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
at study inclusion
mCAV status influences diastolic strain in echocardiography
Time Frame: at study inclusion
diastolic strain is measured by speckle tracking analysis with afterload increase
at study inclusion
mCAV status influences cardiac deformity
Time Frame: at study inclusion
cardiac deformity analysis are performed by MRI
at study inclusion
mCAV status influences grade of fibrosis
Time Frame: at study inclusion
fibrosis grades are measured by MRI
at study inclusion
mCAV status influences extracellular volume
Time Frame: at study inclusion
extracellular volume is measured by MRI
at study inclusion
mCAV status influences the circulating miRNA profile
Time Frame: at study inclusion
circulating miRNA profile is measured by miRNAseq
at study inclusion

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Heart Institute

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mCAV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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