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

NCT ID: NCT02448485

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2025-10-31

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.

Conditions

Aortic Stenosis; Heart Failure; Syncope; Angina Pectoris

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Aortic Valve Intervention

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

Aortic Valve Intervention (surgical or transcatheter)

Intervention Type: PROCEDURE

Surgical or interventional aortic valve implantation

Conservative Treatment

Asymptomatic patients with aortic stenosis followed conservatively at our department

No interventions assigned to this group

Interventions

Aortic Valve Intervention (surgical or transcatheter)

Surgical or interventional aortic valve implantation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• aortic stenosis detected by echocardiography / invasively

Exclusion Criteria

• acute coronary syndrome
• endocarditis

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University Innsbruck

OTHER

Sponsor Role: lead

Responsible Party

Wolfgang Dichtl, MD PhD

Priv.-Doz. DDr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wolfgang Dichtl, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University Innsbruck

Locations

Medical University Innsbruck

Innsbruck, Tyrol, Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Wolfgang Dichtl, MD, PhD

Role: CONTACT

dichtl@me.com

004351250481388

Fabian Barbieri

Role: CONTACT

fabian.barbieri@i-med.ac.at

00436642042968

Facility Contacts

Wolfgang Dichtl, MD PhD

Role: primary

dichtl@me.com

4351250481388

Fabian Barbieri, MD

Role: backup

fabian.barbieri@i-med.ac.at

435126642042968

Other Identifiers

TASS-2

Identifier Type: -

Identifier Source: org_study_id