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

Heart Failure Clinical Trial

— TASS-2  

Official title:

High-Sensitivity Troponin T Plasma Levels in Patients With Aortic Stenosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02448485
• Other study ID #: TASS-2
• Status: Recruiting
• Start date: June 2015
• Est. completion date: October 2025

Study information

• Verified date: March 2023
• Source: Medical University Innsbruck
• Contact: Wolfgang Dichtl, MD, PhD
• Phone: 004351250481388
• Email: dichtl[@]me.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• aortic stenosis detected by echocardiography / invasively

Exclusion Criteria:

• acute coronary syndrome

• endocarditis

Related Conditions & MeSH terms

• Angina Pectoris
• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic
• Heart Failure
• Syncope

Intervention

Procedure:
• Aortic Valve Intervention (surgical or transcatheter)
Surgical or interventional aortic valve implantation

Locations

Country	Name	City	State
Austria	Medical University Innsbruck	Innsbruck	Tirol

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality (overall, cardiovascular)		up to 8 years