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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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.

Austria1 site
  • Medical University Innsbruck

    Innsbruck, Tyrol, 6020

Other trials in Austria

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.

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 groups in NCT02448485
Study groupRoleWhat they receive
Aortic Valve InterventionConsecutive 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 TreatmentAsymptomatic 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.

  1. 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.

  1. First posted19 May 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionOct 2025
  4. Study completionOct 2025

Resources

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)
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

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