An observational study in Aortic Stenosis and Heart Failure, sponsored by Medical University of Warsaw. Status unknown at 1 site in Poland. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-06-05.
Sponsored by Medical University of Warsaw · Observational
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 70 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Medical University of Warsaw is the lead sponsor of 316 studies on the registry; 87 are open to participants now.
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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.
Exclusion Criteria:
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.
Also known as: N-terminal pro-brain natriuretic peptide measurement, echocardiography, biopsy of a myocardium in patients undergoing surgical aortic valve replacement
Correlation between the serum and urine trimethylamine N-oxide concentration and aortic valve area index
Time frame: January 15, 2019 - February 15, 2023
Correlation between the serum and urine trimethylamine N-oxide concentration and (i) other echocardiographic, (ii) biochemical and (iii) histopathological parameters of heart failure.
Time frame: 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.
Time frame: January 15, 2019 - February 15, 2023
Plan to share: Undecided — The individual participant shared only in case the identity of the participant has been made unrecognizable.
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Medical University of Warsaw