Cardiac Allograft VasculopathymCAVNCT05826444
Microvascular Cardiac Allograft Vasculopathy Trial
An observational study of Cardiac Allograft Vasculopathy, run by German Heart Institute at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Allograft Vasculopathy
- What is being tested?
- Echocardiography, Magnetic resonance imaging and Magnetocardiography
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Heart transplant recipients
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
DHZC Deutsches Herzzentrum der Charité
Berlin, 13353
Isabell Just, MD, 00493045932025, isabell.just-lauer@charite.de
About this study
Official title: 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).
- Conditions
- Cardiac Allograft Vasculopathy
- Being tested
- Echocardiography, Magnetic resonance imaging, Magnetocardiography, Histology, Genetics
- Keywords
- heart transplantation, cardiac allograft vasculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
Echocardiography with afterload change
Magnetic resonance imagingDiagnostic test
Stress-MRI
MagnetocardiographyDiagnostic test
Magnetocardiography
HistologyDiagnostic test
Histological analysis
GeneticsDiagnostic test
miRNA sequencing
calcium signalingDiagnostic test
cardiomyocyte calcium signaling
IMRDiagnostic test
Index of microvascular resistance measurement
Angio-IMRDiagnostic test
Angiography derived post-processing index if microvascular resistance
| Study group | Role | What they receive |
|---|---|---|
| microvascular cardiac allograft vasculopathy | Heart transplant recipients with microvascular cardiac allograft vasculopathy defined by histopathology and invasive index of microvascular resistance. Receives: Diagnostic Test: 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 | |
| control | Heart transplant recipients without microvascular cardiac allograft vasculopathy defined by histopathology and invasive index of microvascular resistance. Receives: Diagnostic Test: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
mCAV status influences pw-doppler wall motion analysis in echocardiography
pw-doppler wall motion analysis is measured with afterload increase
Measured: at study inclusion
mCAV status influences global longitudinal strain in echocardiography
global longitudinal strain is measured by speckle tracking analysis with afterload increase
Measured: at study inclusion
mCAV status influences diastolic strain in echocardiography
diastolic strain is measured by speckle tracking analysis with afterload increase
Measured: at study inclusion
mCAV status influences cardiac deformity
cardiac deformity analysis are performed by MRI
Measured: at study inclusion
mCAV status influences grade of fibrosis
fibrosis grades are measured by MRI
Measured: at study inclusion
mCAV status influences extracellular volume
extracellular volume is measured by MRI
Measured: at study inclusion
mCAV status influences the circulating miRNA profile
circulating miRNA profile is measured by miRNAseq
Measured: at study inclusion
Secondary outcomes (3)
mCAV status influences the intrinsic cardiac magnetic field
the intrinsic cardiac magnetic field is measured by magnetocardiography
Measured: at study inclusion
mCAV status influences the cellular calcium signaling
the cellular calcium is visualized by confocal laser microscopy using electrical stimulation
Measured: at study inclusion
mCAV status influences subcellular structures
mitochondria, T-tubuli are described after visualization by confocal laser microscopy
Measured: at study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start1 Oct 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Allograft VasculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Deutsche Stiftung für Herzforschung
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826444
- Sponsor's protocol ID
- mCAV
- Acronym
- mCAV
- Status last verified
- Jul 2024
- First submitted
- 13 Mar 2023
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological and Functional Phenotype of Isolated Microvascular Cardiac Allograft Vasculopathy in Heart Transplant Recipients
- ClinicalTrials.gov ID
- NCT05826444
- Acronym / sponsor ID
- mCAV / mCAV
- Conditions
- Cardiac Allograft Vasculopathy
- Keywords
- heart transplantation, cardiac allograft vasculopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- German Heart InstituteUniversity, hospital or other
- Collaborators
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Deutsche Stiftung für Herzforschung
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| microvascular cardiac allograft vasculopathy | – | Diagnostic Test: 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-IMRHeart transplant recipients with microvascular cardiac allograft vasculopathy defined by histopathology and invasive index of microvascular resistance. |
| control | – | Diagnostic Test: 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-IMRHeart transplant recipients without microvascular cardiac allograft vasculopathy defined by histopathology and invasive index of microvascular resistance. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Heart transplant recipients
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyEchocardiography with afterload change | Diagnostic test | control, microvascular cardiac allograft vasculopathy |
| Magnetic resonance imagingStress-MRI | Diagnostic test | control, microvascular cardiac allograft vasculopathy |
| MagnetocardiographyMagnetocardiography | Diagnostic test | control, microvascular cardiac allograft vasculopathy |
| HistologyHistological analysis | Diagnostic test | control, microvascular cardiac allograft vasculopathy |
| GeneticsmiRNA sequencing | Diagnostic test | control, microvascular cardiac allograft vasculopathy |
| calcium signalingcardiomyocyte calcium signaling | Diagnostic test | control, microvascular cardiac allograft vasculopathy |
| IMRIndex of microvascular resistance measurement | Diagnostic test | control, microvascular cardiac allograft vasculopathy |
| Angio-IMRAngiography derived post-processing index if microvascular resistance | Diagnostic test | control, microvascular cardiac allograft vasculopathy |
Primary outcome
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
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
mCAV status influences diastolic strain in echocardiography
Time frame: at study inclusion
diastolic strain is measured by speckle tracking analysis with afterload increase
mCAV status influences cardiac deformity
Time frame: at study inclusion
cardiac deformity analysis are performed by MRI
mCAV status influences grade of fibrosis
Time frame: at study inclusion
fibrosis grades are measured by MRI
mCAV status influences extracellular volume
Time frame: at study inclusion
extracellular volume is measured by MRI
mCAV status influences the circulating miRNA profile
Time frame: at study inclusion
circulating miRNA profile is measured by miRNAseq
3 secondary outcomes
mCAV status influences the intrinsic cardiac magnetic field
Time frame: at study inclusion
mCAV status influences the cellular calcium signaling
Time frame: at study inclusion
mCAV status influences subcellular structures
Time frame: at study inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Cardiac Allograft Vasculopathy
RecruitingObservational study
Real-World Outcomes of Drug-Coated Balloon Angioplasty in Coronary Artery Disease
Coronary Artery Disease
RecruitingPhase 3
AERIAL Trial: Antiplatelet Therapy in Heart Transplantation
Cardiac Allograft Vasculopathy, Heart Transplant
Recruiting
MARINER Trial: Multiparametric Cardiac PET for CAV Surveillance After Heart Transplantation
Cardiac Allograft Vasculopathy
Active, not recruitingObservational study
Early Post Transplant Cardiac Allograft Vasculopathy
Cardiac Allograft Vasculopathy
Not yet recruitingObservational study
Comparing PCCT With ICA and IVUS in Detecting Cardiac Allograft Vasculopathy
Cardiac Allograft Vasculopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Allograft Vasculopathy, run by German Heart Institute at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mCAV status influences pw-doppler wall motion analysis in echocardiography (time frame: at study inclusion). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.