Aortic StenosisTASS-2NCT02448485
High-Sensitivity Troponin T Plasma Levels in Patients With Aortic Stenosis (Tyrolean Aortic Stenosis Study-2)
An observational study of Aortic Stenosis and Heart Failure, run by Medical University Innsbruck at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Stenosis, Heart Failure, Syncope
- What is being tested?
- Aortic Valve Intervention (surgical or transcatheter)
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2015to Oct 2025
- Phase
- Observational
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: One patient cohort consists of patients with severe symptomatic aortic stenosis admitted for planned valve operation since 2010, when involved institutions started to routinely analyse hsTnT plasma levels. The other patient cohort consists of asymptomatic patients with aortic stenosis diagnosed treated conservatively.
Who may be able to join
- aortic stenosis detected by echocardiography / invasively
Who cannot join
- acute coronary syndrome
- endocarditis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-Sensitivity Troponin T Plasma Levels in Patients With Aortic Stenosis
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.
Read the 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.
- Conditions
- Aortic Stenosis, Heart Failure, Syncope, Angina Pectoris
- Being tested
- Aortic Valve Intervention (surgical or transcatheter)
- Medical subject headings
- Aortic Valve Stenosis, Heart Failure, Syncope, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic Valve Intervention (surgical or transcatheter)Procedure or surgery
Surgical or interventional aortic valve implantation
| Study group | Role | What they receive |
|---|---|---|
| Aortic Valve Intervention | Consecutive symptomatic patients who underwent aortic valve intervention (SAVR or TAVI) for the treatment of severe AS since 2010 Receives: Procedure: Aortic Valve Intervention (surgical or transcatheter) | |
| Conservative Treatment | Asymptomatic patients with aortic stenosis followed conservatively at our department |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality (overall, cardiovascular)
Measured: up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2025
- Study completionOct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wolfgang Dichtl, MD PhD MSc, Medical University Innsbruck
- Investigators
- Wolfgang Dichtl, MD, PhD, Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448485
- Sponsor's protocol ID
- TASS-2
- Acronym
- TASS-2
- Status last verified
- Oct 2026
- First submitted
- 15 May 2015
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No