TMAO in Patients With Severe Aortic Stenosis

Heart Failure Clinical Trial

— TASTE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04406805
• Other study ID #: KB/211/2018
• Status: Recruiting
• Start date: January 15, 2019
• Est. completion date: February 15, 2023

Study information

• Verified date: March 2020
• Source: Medical University of Warsaw
• Contact: Aleksandra Gasecka, MD
• Phone: +48225991951
• Email: gaseckaa[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: February 15, 2023
• Est. primary completion date: February 15, 2022
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic
• Heart Failure

Intervention

Diagnostic Test:
• Measurement of plasma and urine trimethylamine-N-oxide concentration
Information already included in arm/group descriptions.

Locations

Country	Name	City	State
Poland	1st Chair and Department of Cardiology and Department of Cardiosurgery, Medical University of Warsaw	Warsaw	Masovia

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Jaworska K, Hering D, Mosieniak G, Bielak-Zmijewska A, Pilz M, Konwerski M, Gasecka A, Kaplon-Cieslicka A, Filipiak K, Sikora E, Holyst R, Ufnal M. TMA, A Forgotten Uremic Toxin, but Not TMAO, Is Involved in Cardiovascular Pathology. Toxins (Basel). 2019 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between the serum and urine trimethylamine N-oxide concentration and aortic valve area index		January 15, 2019 - February 15, 2023
Secondary	Correlation between the serum and urine trimethylamine N-oxide concentration and (i) other echocardiographic, (ii) biochemical and (iii) histopathological parameters of heart failure.		January 15, 2019 - February 15, 2023
Secondary	Correlation between the baseline trimethylamine N-oxide concentrations and the post-treatment clinical status, as well as the post-treatment echocardiographic and biochemical parameters.		January 15, 2019 - February 15, 2023