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TASTE: TMAO in Patients With Severe Aortic Stenosis

Sponsor
Medical University of Warsaw (Other)
Overall Status
Recruiting
CT.gov ID
NCT04406805
Collaborator
(none)
70
Enrollment
1
Location
49
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Measurement of plasma and urine trimethylamine-N-oxide concentration

Study Design

Study Type:
Observational
Anticipated Enrollment :
70 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Jan 15, 2019
Anticipated Primary Completion Date :
Feb 15, 2022
Anticipated Study Completion Date :
Feb 15, 2023

Arms and Interventions

Arm Intervention/Treatment
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
Information already included in arm/group descriptions.
Other Names:
  • N-terminal pro-brain natriuretic peptide measurement, echocardiography, biopsy of a myocardium in patients undergoing surgical aortic valve replacement

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between the serum and urine trimethylamine N-oxide concentration and aortic valve area index [January 15, 2019 - February 15, 2023]

    Secondary Outcome Measures

    1. 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]

    2. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Medical University of Warsaw

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medical University of Warsaw
    ClinicalTrials.gov Identifier:
    NCT04406805
    Other Study ID Numbers:
    • KB/211/2018
    First Posted:
    May 28, 2020
    Last Update Posted:
    Jun 5, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Medical University of Warsaw
    Aortic Stenosis
    Heart Failure
    Trimethylamine
    TMAO
    Bacterial Metabolites
    Additional relevant MeSH terms:
    Heart Failure
    Aortic Valve Stenosis
    Constriction, Pathologic
    Natriuretic Peptide, Brain

    Study Results

    No Results Posted as of Jun 5, 2020