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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measurement of plasma and urine trimethylamine-N-oxide concentration | Diagnostic Test | Information already included in arm/group descriptions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between the serum and urine trimethylamine N-oxide concentration and aortic valve area index | January 15, 2019 - February 15, 2023 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aleksandra Gąsecka, MD | Contact | +48225991951 | gaseckaa@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1st Chair and Department of Cardiology and Department of Cardiosurgery, Medical University of Warsaw | Recruiting | Warsaw | Masovia | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31454905 | Result | 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. |
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The individual participant shared only in case the identity of the participant has been made unrecognizable.
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Plasma and urine samples for trimethylamine-N-oxide analysis with a ultra performance liquid chromatograph coupled with a mass spectrometer
|
| January 15, 2019 - February 15, 2023 |
| D014694 |
| Ventricular Outflow Obstruction |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |