TMAO in Patients With Severe Aortic Stenosis

NCT04406805 | Unknown

• 1 other identifier: KB/211/2018
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Aortic Stenosis; Heart Failure; Trimethylamine; TMAO; Bacterial Metabolites

Outcome Measures

Primary Outcomes (1)

• Correlation between the serum and urine trimethylamine N-oxide concentration and aortic valve area index

  January 15, 2019 - February 15, 2023

Secondary Outcomes (2)

• 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

• 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

Study Arms (1)

Severe aortic stenosis

Patients will be enrolled among those who will be (i) aged from 18 to 99 years, (ii) admitted to the hospital due to severe aortic stenosis, and (iii) qualified for treatment with either surgical aortic valve replacement or transcatheter aortic valve implantation

Diagnostic Test: Measurement of plasma and urine trimethylamine-N-oxide concentration

Interventions

Measurement of plasma and urine trimethylamine-N-oxide concentration DIAGNOSTIC_TEST

Information already included in arm/group descriptions.

Also known as: N-terminal pro-brain natriuretic peptide measurement, echocardiography, biopsy of a myocardium in patients undergoing surgical aortic valve replacement

Severe aortic stenosis

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will be enrolled among those who will be (i) aged from 18 to 99 years, (ii) admitted to the 1st Chair and Department of Cardiology or Department of Cardiosurgery, Medical University of Warsaw due to severe AS, and (iii) qualified for treatment with either surgical aortic valve replacement or transcatheter aortic valve implantation.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

1st Chair and Department of Cardiology and Department of Cardiosurgery, Medical University of Warsaw

Warsaw, Masovia, Poland

RECRUITING

Related 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 Aug 26;11(9):490. doi: 10.3390/toxins11090490.

  PMID: 31454905 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and urine samples for trimethylamine-N-oxide analysis with a ultra performance liquid chromatograph coupled with a mass spectrometer

MeSH Terms

Conditions

Aortic Valve Stenosis; Heart Failure

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Central Study Contacts

Aleksandra Gąsecka, MD

CONTACT

+48225991951; gaseckaa@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 28, 2020
• Study Start: January 15, 2019
• Primary Completion: February 15, 2022
• Study Completion: February 15, 2023
• Last Updated: June 5, 2020

Record last verified: 2020-03

Locations

PL (1)