Aortic StenosisTASTENCT04406805
TMAO in Patients With Severe Aortic Stenosis
An observational study of Aortic Stenosis and Heart Failure, run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Aortic Stenosis, Heart Failure
- What is being tested?
- Measurement of plasma and urine trimethylamine-N-oxide concentration
- How many people
- 70 participants
- Where
- 1 sitePoland
- Study dates
- 15 Jan 2019to 15 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
1st Chair and Department of Cardiology and Department of Cardiosurgery, Medical University of Warsaw
Warsaw, Masovia
Aleksandra Gąsecka, PhD, +48225991951, gaseckaa@gmail.com
Agnieszka Kapłon-Cieślicka, Ass. Prof.
About this study
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
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
- Being tested
- Measurement of plasma and urine trimethylamine-N-oxide concentration
- Keywords
- Aortic Stenosis, Heart Failure, Trimethylamine, TMAO, Bacterial Metabolites
- Medical subject headings
- Aortic Valve Stenosis, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of plasma and urine trimethylamine-N-oxide concentrationDiagnostic test
Also called N-terminal pro-brain natriuretic peptide measurement, echocardiography, biopsy of a myocardium in patients undergoing surgical aortic valve replacement
Information already included in arm/group descriptions.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Measurement of plasma and urine trimethylamine-N-oxide concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the serum and urine trimethylamine N-oxide concentration and aortic valve area index
Measured: 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.
Measured: 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.
Measured: January 15, 2019 - February 15, 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start15 Jan 2019
- Primary completion15 Feb 2022 (estimated)
- Study completion15 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406805
- Sponsor's protocol ID
- KB/211/2018
- Acronym
- TASTE
- Status last verified
- Mar 2020
- First submitted
- 22 May 2020
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The individual participant shared only in case the identity of the participant has been made unrecognizable.
Publications
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.
PubMed 31454905
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04406805
- Acronym / sponsor ID
- TASTE / KB/211/2018
- Conditions
- Aortic Stenosis, Heart Failure
- Keywords
- Aortic Stenosis, Heart Failure, Trimethylamine, TMAO, Bacterial Metabolites
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 15 Feb 2022 (estimated)
- Study completion
- 15 Feb 2023 (estimated)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe aortic stenosis | – | Diagnostic Test: Measurement of plasma and urine trimethylamine-N-oxide concentrationPatients 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of plasma and urine trimethylamine-N-oxide concentrationAlso: N-terminal pro-brain natriuretic peptide measurement, echocardiography, biopsy of a myocardium in patients undergoing surgical aortic valve replacementInformation already included in arm/group descriptions. | Diagnostic test | Severe aortic stenosis |
Primary outcome
Correlation between the serum and urine trimethylamine N-oxide concentration and aortic valve area index
Time frame: January 15, 2019 - February 15, 2023
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Results publication: PubMed 31454905Jaworska 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.
- Individual participant dataSharing planned: Undecided. The individual participant shared only in case the identity of the participant has been made unrecognizable.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis and Heart Failure, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aleksandra Gąsecka, MD (+48225991951, gaseckaa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the serum and urine trimethylamine N-oxide concentration and aortic valve area index (time frame: January 15, 2019 - February 15, 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04406805, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.