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NCT Number: NCT07101575

Cardiac Evaluation in Hereditary Hemorrhagic Telangiectasia

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients > 10 years of age with a genetic diagnosis, i.e. a pathogenic mutation in the endoglin (ENG), activin receptor A (ACVRL1) or small mother against decapentaplegic (SMAD4) gene, and/or a clinically confirmed diagnosis of hereditary hemorrhagic teleangectasia (HHT) according to the Curaçao criteria
  • Signed informed consent

Exclusion criteria

  • Patients whose echocardiographic images are of suboptimal quality and cannot be adequately analysed.
  • No signed informed consent

Treatment and study plan

Transthoracic echocardiography

Diagnostic Test

Transthoracic echocardiography with bubble test, by intravenous infusion of agitate saline solution

Primary outcomes

  1. Evaluation of suclinical cardiac mechanical dysfunction

    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

Secondary outcomes

  1. Genotype-phenotype correlations

    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

  2. Impact of chronic anaemia

    Time frame: 6 months

    Verify the impact of chronic anaemia and iron supplementation on cardiac mechanics in relation to possible genotype-phenotype interactions

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriella Locorotondo

CONTACT

[email protected]

+39 0630154187

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Cardiac Observational Study of Patients With Hereditary Hemorrhagic Telangiectasia

Acronym: CARDI-HHT

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Aug 3, 2025
Registry last updated
Aug 14, 2025

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.

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