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RecruitingNCT02448485TASS-2Updated Aug 1, 2024

High-Sensitivity Troponin T Plasma Levels in Patients With Aortic Stenosis (Tyrolean Aortic Stenosis Study-2)

An observational study in Aortic Stenosis, Heart Failure and Syncope, sponsored by Medical University Innsbruck. Recruiting at 1 site in Austria. Per ClinicalTrials.gov, last updated 2024-08-01.

Sponsored by Medical University Innsbruck · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
10,000
Sex
All
01

Study 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 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.

02

Conditions studied

  • Aortic Stenosis
  • Heart Failure
  • Syncope
  • Angina Pectoris
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • aortic stenosis detected by echocardiography / invasively

Exclusion criteria

Exclusion Criteria:

  • acute coronary syndrome
  • endocarditis
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
10,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Aortic Valve Intervention

    Consecutive symptomatic patients who underwent aortic valve intervention (SAVR or TAVI) for the treatment of severe AS since 2010

    Procedure: Aortic Valve Intervention (surgical or transcatheter)

  • Conservative Treatment

    Asymptomatic patients with aortic stenosis followed conservatively at our department

Interventions

  • ProcedureAortic Valve Intervention (surgical or transcatheter)

    Surgical or interventional aortic valve implantation

05

What researchers measure

Primary outcomes

  1. Mortality (overall, cardiovascular)

    Time frame: up to 8 years

06

Study locations

1 of 1 sites recruiting
  • Medical University Innsbruck
    Innsbruck, Tirol 6020, Austria
    Recruiting
07

Registry details

Key details

Study ID
NCT02448485
Lead sponsor
Medical University Innsbruck
Responsible party
Wolfgang Dichtl, MD PhD (Priv.-Doz. DDr., Medical University Innsbruck) — Principal investigator
First posted
May 19, 2015
Start date
Jun 2015
Primary completion
Oct 2025 (estimated)
Completion
Oct 2025 (estimated)
Last update
Aug 1, 2024

Study contacts

Wolfgang Dichtl, MD, PhD
Contact
dichtl@me.com
004351250481388
Fabian Barbieri
Contact
fabian.barbieri@i-med.ac.at
00436642042968
Wolfgang Dichtl, MD, PhD
principal investigator · Medical University Innsbruck

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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