Brief Title
High-Sensitivity Troponin T Plasma Levels in Patients With Aortic Stenosis (Tyrolean Aortic Stenosis Study-2)
Official Title
High-Sensitivity Troponin T Plasma Levels in Patients With Aortic Stenosis
Brief Summary
TASS-2 (Tyrolean Aortic Stenosis Study-2) aims to characterize the clinical value of minimally elevated troponin T plasma levels both in patients with asymptomatic and symtomatic aortic stenosis.
Detailed Description
Development of symptoms such as heart failure, syncope or angina pectoris is the well-established indication for valve operation in patients with severe aortic stenosis. However, many patients tend to misinterpretate or even ignore symptom onset, and irreversible myocardial dysfunction may occur. Measurement of aortic valve area by transthoracic echocardiography using the continuity equation is prone to methological mistakes, whereas transvalvular gradients are usually easy to quantify but may underestimate hemodynamic effects in the presence of low flow (stroke volume index below 35 ml/m2). All these shortcomings in clinical routine may be overcome by objectively and easily assessable parameters indicating advanced aortic stenosis. Severe aortic valve calcification is such a risk factor for worse prognosis. However, assessment of valve calcification by echocardiography is a subjective measurement and highly operator-dependent. Quantification of valve calcification by multi detector computed tomography is limited by exposure to radiation, availibilty and cost. A laboratory parameter already used in clinical routine would fullfill the requirements for such a risk stratification much better. Natriuretic peptides may be of interest in this context, but their plasma levels are strongly influenced by age, sex, concomitant arterial hypertension and/or renal dysfunction and volume status. Recently, high-sensitivity troponin plasma levels have been suggested to indicate ongoing myocardial fibrosis in aortic stenosis. A small study with 60 patients suggested that hs-TnT predicte the operative outcome of AS. We therefore set out to characterize the clinical value of minimally elevated troponin T plasma levels both in patients with asymptomatic and symtomatic aortic stenosis.
Study Type
Observational
Primary Outcome
Mortality (overall, cardiovascular)
Condition
Aortic Stenosis
Intervention
Aortic Valve Intervention (surgical or transcatheter)
Study Arms / Comparison Groups
Aortic Valve Intervention
Description: Consecutive symptomatic patients who underwent aortic valve intervention (SAVR or TAVI) for the treatment of severe AS since 2010
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
10000
Start Date
June 2015
Completion Date
October 2025
Primary Completion Date
October 2025
Eligibility Criteria
Inclusion Criteria: - aortic stenosis detected by echocardiography / invasively Exclusion Criteria: - acute coronary syndrome - endocarditis
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Wolfgang Dichtl, MD, PhD, 004351250481388, [email protected]
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT02448485
Organization ID
TASS-2
Responsible Party
Principal Investigator
Study Sponsor
Medical University Innsbruck
Study Sponsor
Wolfgang Dichtl, MD, PhD, Principal Investigator, Medical University Innsbruck
Verification Date
October 2021