TMAO in Patients With Severe Aortic Stenosis

  • STATUS
    Recruiting
  • participants needed
    70
  • sponsor
    Medical University of Warsaw
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Updated on 19 February 2024
See if I qualify
cardiovascular disease
heart disease
stenosis
aortic valve replacement
valvular disease
heart failure
transcatheter aortic valve implantation
aortic stenosis

Summary

Trimethylamine N-oxide (TMAO) has recently gained increasing scientific interest in the field of cardiovascular disease, including its role in cell protection against osmotic and hydrostatic stress. Aortic stenosis (AS) is the most common valvular heart disease, affecting about 7.6 million people over 75 years of age in North America and Europe alone. We hypothesized that TMAO plays a role in protection of the cardiomyocytes against pressure overload in patients with AS. The primary aim of this study is to assess the correlation between the serum and urine TMAO concentration, and (i) echocardiographic, (ii) biochemical and (iii) histopathological parameters of heart failure in patients with severe AS. The secondary aim of this study is to evaluate a correlation between the baseline TMAO concentrations and the post-treatment clinical status, as well as the post-treatment echocardiographic and biochemical parameters.

Details
Condition Aortic Stenosis, Heart failure, Heart failure, Heart disease, Heart disease, VALVULAR HEART DISEASE
Age 18years - 99years
Treatment Measurement of plasma and urine trimethylamine-N-oxide concentration
Clinical Study IdentifierNCT04406805
SponsorMedical University of Warsaw
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Informed consent to participate in the study
Severe aortic stenosis, defined as aortic valve area <1.0 cm2 or aortic valve area index <0.6 cm2/m2 as calculated by the continuity equation on transthoracic echocardiography, regardless of the transvalvular gradient, with or without coexisting symptoms of heart failure
Qualification for surgical aortic valve replacement or transcatheter aortic valve implantation by the Heart Team in accordance with European Society of Cardiology guidelines

Exclusion Criteria

Heart failure of etiology other than aortic stenosis
Coexisting, haemodynamically significant aortic regurgitation
Myocardial infarction within the last 3 months
Coronary revascularization within the last month or planned during transcatheter aortic valve implantation or surgical aortic valve replacement
Chronic kidney disease with estimated glomerular filtration rate <45 ml/min/1.73 m2
Acute gastrointestinal disease within the last month
Active neoplastic disease
Chronic inflammatory disease
Autoimmune disease
Chronic intestinal disease
Antibiotic therapy within the last 2 months
Dietary supplements within the last 7 days
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