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

Sponsor
Medical University Innsbruck (Other)
Overall Status
Recruiting
CT.gov ID
NCT02448485
Collaborator
(none)
10,000
1
124
80.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Aortic Valve Intervention (surgical or transcatheter)

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
10000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
High-Sensitivity Troponin T Plasma Levels in Patients With Aortic Stenosis
Actual Study Start Date :
Jun 1, 2015
Anticipated Primary Completion Date :
Oct 1, 2025
Anticipated Study Completion Date :
Oct 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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)
Surgical or interventional aortic valve implantation

Conservative Treatment

Asymptomatic patients with aortic stenosis followed conservatively at our department

Outcome Measures

Primary Outcome Measures

  1. Mortality (overall, cardiovascular) [up to 8 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • aortic stenosis detected by echocardiography / invasively
Exclusion Criteria:
  • acute coronary syndrome

  • endocarditis

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University Innsbruck Innsbruck Tirol Austria 6020

Sponsors and Collaborators

  • Medical University Innsbruck

Investigators

  • Principal Investigator: Wolfgang Dichtl, MD, PhD, Medical University Innsbruck

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wolfgang Dichtl, MD PhD, Priv.-Doz. DDr., Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT02448485
Other Study ID Numbers:
  • TASS-2
First Posted:
May 19, 2015
Last Update Posted:
Oct 26, 2021
Last Verified:
Oct 1, 2021

Study Results

No Results Posted as of Oct 26, 2021