Transthoracic echocardiography
Diagnostic TestTransthoracic echocardiography with bubble test, by intravenous infusion of agitate saline solution
NCT Number: NCT07101575
Hereditary haemorrhagic telangiectasia (HHT) is a rare autosomal dominant genetic disease associated with mutations in genes encoding proteins of the transforming growth factor β (TGF-β) family, i.e. endoglin (ENG), activin receptor A (ACVRL1), and SMAD 4 (small mother against decapentaplegic 4). Mutations in any of these genes lead to the onset of arteriovenous malformations (AVMs). The clinical consequences of this syndrome are primarily AVM-associated complications.
Major cardiovascular consequences occur in the more advanced stages, but their prevalence is low. Most HHT patients are asymptomatic, and ischemic heart disease has a significantly lower prevalence than in the general population. The limited sample size of studies currently published in the literature makes it difficult to characterize any subclinical cardiovascular alterations in asymptomatic HHT subjects.
Alterations in TGF-β family proteins likely result in a protective effect on the coronary circulation against atherosclerosis. A thorough understanding of the potential protective factors against coronary artery disease, underlying HHT alterations, may allow the development of gene therapy models inspired by the HHT phenotype. Some manifestations of extracellular matrix remodelling at the tissue level (i.e. myocardial and valvular) may be more prevalent in HHT patients than in the general population. Finally, any subclinical alterations in cardiac function related to chronic anaemia and possible iron overload due to iron replacement therapy are not yet known.
Primary objective of the study will be to perform a complete echocardiographic characterization, using new imaging methods aimed at identifying even subclinical dysfunctions of cardiac mechanics, including a phenotyping of the morphology and function of the valvular systems, as well as paradoxical shunts.
Secondary objectives of the study will be: 1) To verify whether there are echocardiographic differences, related to extracellular matrix remodelling, in addition to the presence of shunts, between the various HHT genotypes and to identify any genotype-phenotype correlations. 2)To verify the impact of chronic anaemia and iron supplementation on cardiac mechanics in relation to possible genotype-phenotype interactions.
About study methodology, collection and analysis of clinical and echocardiographic data will be obtained from routine cardiac assessments performed as part of the HHT clinical-care pathway.
Trial opening soon.
Get Notified10 year–80 year
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Transthoracic echocardiography with bubble test, by intravenous infusion of agitate saline solution
Time frame: 30 minutes
Perform a comprehensive echocardiographic characterization, using new imaging techniques to identify even subclinical cardiac mechanical dysfunction, including phenotyping of the morphology and function of the valvular systems, as well as paradoxical shunts
Time frame: 6 months
Verify whether there are echocardiographic differences related to extracellular matrix remodelling, in addition to the presence of shunts, between the various hereditary hemorrhagic telangiectasia (HHT) genotypes and identify any genotype-phenotype correlations
Time frame: 6 months
Verify the impact of chronic anaemia and iron supplementation on cardiac mechanics in relation to possible genotype-phenotype interactions
Contact information is provided by the study sponsor or research team.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
Cardiac Observational Study of Patients With Hereditary Hemorrhagic Telangiectasia
Acronym: CARDI-HHT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06259292
Arteriovenous Malformations, Brain Diseases
Birmingham, Alabama, United States
View Trial DetailsNCT06659640
Cardiovascular Abnormalities, Cardiovascular Diseases
Birmingham, Alabama, United States
View Trial DetailsNCT07623525
Cardiovascular Abnormalities, Cardiovascular Diseases
Camperdown, New South Wales, Australia
View Trial DetailsNCT05641142
Cardiovascular Abnormalities, Cardiovascular Diseases
Angers, France
View Trial Details