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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Aortic Stenosis; Angina Pectoris; Syncope
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Wolfgang Dichtl, MD, PhD; Phone Number: 004351250481388; Email: dichtl@me.com
• Study Contact Backup: Name: Fabian Barbieri; Phone Number: 00436642042968; Email: fabian.barbieri@i-med.ac.at

Study Locations

• Austria
  • Tirol
    • Innsbruck, Tirol, Austria, 6020
      • Recruiting
      • Medical University Innsbruck
      • Contact: Wolfgang Dichtl, MD PhD; Phone Number: 4351250481388; Email: dichtl@me.com
      • Contact: Fabian Barbieri, MD; Phone Number: 435126642042968; Email: fabian.barbieri@i-med.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• 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.

Description

Inclusion Criteria:

• aortic stenosis detected by echocardiography / invasively

Exclusion Criteria:

• acute coronary syndrome
• endocarditis

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality (overall, cardiovascular)	up to 8 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: May 15, 2015
• First Submitted That Met QC Criteria: May 15, 2015
• First Posted (Estimated): May 19, 2015

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 31, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Unconsciousness; Consciousness Disorders; Chest Pain; Aortic Valve Stenosis; Constriction, Pathologic; Syncope; Angina Pectoris
• Other Study ID Numbers: TASS-2