Clinical trials: Endomyocardial Biopsy
Heart Transplant Failure and Rejection
A Comparative Effectiveness Study in Heart Transplant Patients of Rejection Surveillance With Cell-free DNA Versus Endomyocardial Biopsy
This is an open label Comparative Effectiveness Research (CER) study in which patients will be randomized at the site level to Prospera surveillance or EMB surveillance in a 2:1 ratio (Prospera to EMB) at each site.
- Trial name
- ACES-EMB (NCT06414603)
- Testing
- The Prospera™ Test
- Where
- 16 sites in United States
- Volunteers
- 250 people
- Sponsor
- Natera, Inc.
Heart Transplant Failure
Tacrolimus and Personalized Therapy to Prevent Acute Rejection Episodes
Heart transplant is the only effective treatment for people with advanced heart failure. Post-transplant pharmacological therapies are of fundamental importance for the survival of individuals after surgery: although considerable…
- Trial name
- NCT06338306
- Testing
- Tacrolimus（FK506）
- Where
- Italy
- Volunteers
- 25 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
Myocarditis, Heart Failure
ARrhythmias in MYocarditis
Myocarditis promotes the occurrence of serious cardiac arrhythmias and conduction disorders which may lead to sudden cardiac death, the need for catheter ablation of arrhythmia or implantation of a cardioverter-defibrillator or…
- Conditions
- Myocarditis, Heart Failure, Endomyocardial Biopsy, Arrythmia
- Trial name
- ARMY (NCT03801681)
- Testing
- ECG holter monitoring
- Where
- Poland
- Volunteers
- 100 people
- Sponsor
- Medical University of Warsaw
Heart Transplant Rejection
Biomarkers for Diagnosis, Prognosis, and Targeted Therapy After Heart Transplantation
The objective of this prospective observational single center study is to investigate donor-derived cell-free DNA (ddcfDNA), peripheral blood platelet mRNA, peripheral blood extracellular vesicle mRNA, and peripheral blood…
- Trial name
- EMBIO (NCT06064123)
- Testing
- Cell-free DNA
- Where
- Finland
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Helsinki University Central Hospital
Non-ischemic Cardiomyopathy, Dilated Cardiomyopathy (DCM)
Multimodal and Multidisciplinary Approach to Optimize Diagnostic, Prognostic, and Therapeutic Management of Patients with Non-ischemic Cardiomyopathies and Arrhythmogenic-inflammatory Phenotypes: a Multicenter, Observational, Retrospective and Prospective Registry Study.
Non-ischemic cardiomyopathies (NICM) represent a heterogeneous group of pathologies characterized by absence of obstructive disease of the epicardial coronary vessels and distinct structural and functional changes of the…
- Conditions
- Non-ischemic Cardiomyopathy, Dilated Cardiomyopathy (DCM), Hypertrophic Cardiomyopathy (HCM), Restrictive Cardiomyopathy
- Trial name
- AINICM (NCT06607471)
- Testing
- Support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation, Support treatment, cardiac medical treatment, aetiology-specific treatment
- Where
- Italy
- Volunteers
- 15,000 people
- Sponsor
- Scientific Institute San Raffaele
Heart Transplant Rejection
Molecular Diagnosis of Heart Allograft Rejection Using Intra-Graft Targeted Gene Expression Profiling.
The goal of this observational study is to develop and validate a molecular heart rejection diagnostic system based on targeted transcriptome as a novel monitoring companion tool for heart allograft precision diagnostics…
- Trial name
- Nano-Heart (NCT06436027)
- Testing
- Nano-Heart tool: Intra-Graft Targeted Gene Expression Profiling
- Where
- 3 sites in United States, France and 1 more
- Volunteers
- 496 people
- Sponsor
- Paris Translational Research Center for Organ Transplantation
Myocarditis, Ventricular Arrhythmia
Role of Endomyocardial Biopsy and Aetiology-based Treatment in Pediatric Patients with Inflammatory Heart Disease in Arrhythmic and Non-arrhythmic Clinical Presentations: an Integrated Approach for the Optimal Diagnostic and Therapeutic Management (MYOPED)
Myocarditis is a complex inflammatory disease, usually occurring secondary to viral infections, autoimmune processes or toxic agents.
- Conditions
- Myocarditis, Ventricular Arrhythmia, Inflammatory Cardiomyopathy, Genetic Predisposition
- Trial name
- MYOPED (NCT06591260)
- Testing
- support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation
- Where
- Italy
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Scientific Institute San Raffaele
Myocarditis
Acute Eosinophilic Myocarditis International Registry
Retrospective collection of clinical, histological, imaging data regarding patients with acute histologically-proven eosinophilic myocarditis.
- Trial name
- NCT06447935
- Testing
- No intervention
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Niguarda Hospital
Myocarditis, Sudden Cardiac Death
Occurrence, Trends, Management and Outcomes of Patients Hospitalized With Myocarditis
The epidemiology of myocarditis is largely unknown and based mainly on small single-center studies. The study aim to evaluate the current incidence, clinical characteristics and outcomes of patients hospitalized due to…
- Conditions
- Myocarditis, Sudden Cardiac Death, Cardiomyopathies, Arrythmia
- Trial name
- MYO-PL (NCT04827706)
- Where
- Poland
- Volunteers
- 19,978 people
- Sponsor
- Medical University of Warsaw
Heart Transplantation
Superiority Assessment of Donor-derived Cell-FreE DNA ( Deoxyribonucleic Acid) for Cardiac Allograft REjection Monitoring
Heart transplantation (HTx) remains the gold-standard treatment for patients with end-stage heart failure refractory to the medical management, offering the best survival and quality of life.
- Trial name
- SAFE-CARE (NCT07897526)
- Testing
- non-invasive strategy based of the analysis of circulating dd-cfDNA (AlloSeq cfDNA assay), control
- Volunteers
- 352 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Myocarditis, Heart Failure
Study to Evaluate the Efficacy of Immunosuppression in Myocarditis or Inflammatory Cardiomyopathy.
Myocarditis can result in numerous complications, but there is paucity of data regarding optimal therapy, short- and long-term effects of possibly effective immunosuppressive therapy.
- Conditions
- Myocarditis, Heart Failure, Endomyocardial Biopsy, Cardiomyopathies, Secondary
- Trial name
- IMPROVE-MC (NCT04654988)
- Testing
- Prednisone, Azathioprine
- Where
- Poland
- Volunteers
- 100 people
- Sponsor
- Medical University of Warsaw
Cardiovascular Disease, Acute Rejection of Cardiac Transplant
Quantitative Detection of Circulating Donor-Specific DNA in Organ Transplant Recipients (DTRT-Multi-Center Study)
The primary goal of this Multicenter Study is to develop and to evaluate a method for measuring donor-specific cell free DNA in blood samples from transplant recipients as markers of rejection.
- Conditions
- Cardiovascular Disease, Acute Rejection of Cardiac Transplant, Cardiac Transplant Rejection, Heart Transplant Failure and Rejection
- Trial name
- DTRT (NCT02109575)
- Testing
- Blood Draw of up to 10 ml
- Where
- 8 sites in United States
- Volunteers
- 540 people
- Sponsor
- Medical College of Wisconsin
Graft Rejection, Heart Diseases
A Comparison of AlloMap Molecular Testing and Traditional Biopsy-based Surveillance for Heart Transplant Rejection Early Post-transplantation
This study is designed to evaluate the safety and efficacy of a peripheral blood mononuclear cell gene expression profiling method (AlloMap) in monitoring asymptomatic heart transplant patients for acute rejection beginning 2-6…
- Trial name
- EIMAGE (NCT00962377)
- Testing
- Endomyocardial biopsy, AlloMap Molecular Testing
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- XDx
Aortic Valve Stenosis, Myocardial Fibrosis
Echocardiography Findings in Patients With Myocardial Fibrosis and Severe Aortic Stenosis
Patients with aortic stenosis waiting for aortic valve repair were investigated with echocardiography preoperatively, and a myocardial biospy was taken during the operation.
- Trial name
- SAS-fibrosis (NCT07331116)
- Testing
- Transthoracic echocardiography, Cardiac magnetic resonance imaging
- Where
- Norway
- Volunteers
- 22 people
- Sponsor
- Norwegian University of Science and Technology
Heart Transplant Rejection, Microvascular Resistance
IMR-Heart Trasplant Study
Acute allograft rejection (AAR) is an important cause of morbi-mortality in heart transplant (HT) patients, particularly during the first year.
- Trial name
- NCT06656065
- Where
- 2 sites in Spain
- Volunteers
- 100 people
- Sponsor
- Hospital Miguel Servet
Inflammatory Cardiomyopathy
CZECH-ICIT (CZECH Inflammatory Cardiomyopathy Immunosuppression Trial)
The aim of this study is to compare the effect of combined immunosuppressive therapy given on the top standard medical therapy of chronic heart failure according to current guidelines with standard medical therapy of chronic…
- Trial name
- NCT01877746
- Testing
- Combination of prednisone and azathioprine, No intervention
- Where
- 2 sites in Czechia
- Volunteers
- 234 people
- Sponsor
- St. Anne's University Hospital Brno, Czech Republic
Pediatric Heart Transplant
Non-invasive Detection of Acute Cell-mediated Graft Rejection in Pediatric Heart Transplant Recipients
Acute cardiac rejection is currently diagnosed by endomyocardial biopsy (EMB), but multiparametric cardiac magnetic resonance (CMR) may be a non-invasive alternative by its capacity for myocardial structure and function…
- Trial name
- NCT06795958
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Myocarditis
FDG-PET/CT Images Comparing to MRI and Endomyocardial Biopsy in Myocarditis
Fifty hospitalized consecutive patients with clinically suspected myocarditis (MC) who meet the inclusion/exclusion criteria will be enrolled to the study.
- Trial name
- STREAM (NCT04085718)
- Volunteers
- 50 people
- Sponsor
- Medical University of Warsaw
Right Heart Catheterization
The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output
The Nanowear SimpleSense study is a single center, prospective, non-randomized, feasibility, non- significant risk study The study will be done in 2 phases.
- Trial name
- NCT05629533
- Testing
- SimpleSense
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Nanowear Inc.
Myocarditis, Ventricular Arrythmia
Role of Endomyocardial Biopsy and Aetiology-based Treatment in Patients With Inflammatory Heart Disease in Arrhythmic and Non-arrhythmic Clinical Presentations: an Integrated Approach for the Optimal Diagnostic and Therapeutic Management
Myocarditis is a complex inflammatory disease, usually occurring secondary to viral infections, autoimmune processes or toxic agents.
- Conditions
- Myocarditis, Ventricular Arrythmia, Inflammatory Cardiomyopathy, Genetic Predisposition
- Trial name
- MYOCAR (NCT04521790)
- Testing
- support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation
- Where
- Italy
- Volunteers
- 1,000 people
- Sponsor
- Scientific Institute San Raffaele