Microvascular Cardiac Allograft Vasculopathy Trial

Cardiac Allograft Vasculopathy Clinical Trial

— mCAV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05826444
• Other study ID #: mCAV
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2023
• Source: German Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Allograft Vasculopathy
• Vascular Diseases

Intervention

Diagnostic Test:
• Echocardiography
Echocardiography with afterload change
• Magnetic resonance imaging
Stress-MRI
• Magnetocardiography
Magnetocardiography
• Histology
Histological analysis
• Genetics
miRNA sequencing
• calcium signaling
cardiomyocyte calcium signaling
• IMR
Index of microvascular resistance measurement
• Angio-IMR
Angiography derived post-processing index if microvascular resistance

Locations

Country	Name	City	State
Germany	DHZC Deutsches Herzzentrum der Charité	Berlin

Sponsors (3)

Lead Sponsor	Collaborator
German Heart Institute	Deutsche Stiftung für Herzforschung, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mCAV status influences pw-doppler wall motion analysis in echocardiography	pw-doppler wall motion analysis is measured with afterload increase	at study inclusion
Primary	mCAV status influences global longitudinal strain in echocardiography	global longitudinal strain is measured by speckle tracking analysis with afterload increase	at study inclusion
Primary	mCAV status influences diastolic strain in echocardiography	diastolic strain is measured by speckle tracking analysis with afterload increase	at study inclusion
Primary	mCAV status influences cardiac deformity	cardiac deformity analysis are performed by MRI	at study inclusion
Primary	mCAV status influences grade of fibrosis	fibrosis grades are measured by MRI	at study inclusion
Primary	mCAV status influences extracellular volume	extracellular volume is measured by MRI	at study inclusion
Primary	mCAV status influences the circulating miRNA profile	circulating miRNA profile is measured by miRNAseq	at study inclusion
Secondary	mCAV status influences the intrinsic cardiac magnetic field	the intrinsic cardiac magnetic field is measured by magnetocardiography	at study inclusion
Secondary	mCAV status influences the cellular calcium signaling	the cellular calcium is visualized by confocal laser microscopy using electrical stimulation	at study inclusion
Secondary	mCAV status influences subcellular structures	mitochondria, T-tubuli are described after visualization by confocal laser microscopy	at study inclusion