NCT04406805

TMAO in Patients With Severe Aortic Stenosis

Concentration of Trimethylamine-N-oxide Versus Echocardiographic, Biochemical and Histopathological Parameters of Heart Failure in Patients With Severe Aortic Stenosis: a Prospective, Observatory Trial

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: —

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.

Conditions

• Aortic Stenosis
• Heart Failure

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Measurement of plasma and urine trimethylamine-N-oxide concentration	Information already included in arm/group descriptions.

Timeline

• Start date: 2019-01-15
• Primary completion: 2022-02-15
• Completion: 2023-02-15
• First posted: 2020-05-28
• Last updated: 2020-06-05

Locations

1 site across 1 country: Poland