Status:
UNKNOWN
TMAO in Patients With Severe Aortic Stenosis
Lead Sponsor:
Medical University of Warsaw
Conditions:
Aortic Stenosis
Heart Failure
Eligibility:
All Genders
18-99 years
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. A...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 15 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04406805
Start Date
January 15 2019
End Date
February 15 2023
Last Update
June 5 2020
Active Locations (1)
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1
1st Chair and Department of Cardiology and Department of Cardiosurgery, Medical University of Warsaw
Warsaw, Masovia, Poland