Effect of TF-TAVR on Emotional Status, Quality of Life, Frailty and Inflammation

Summary

Aortic valve stenosis (AS) shows high and increasing prevalence in Western civilizations and leads to high morbidity and mortality. 15 years ago Alain Cribier performed the first catheter-based transfemoral aortic valve replacement at the University of Rouon. This historical step initiated a dramatic shift in the treatment of AS with more than 50% of patients being treated interventionally instead of the surgical approach, today.

Comorbidities are major determinants of cardiovascular events and clinical outcome in aortic valve stenosis but little is known about psychiatric comorbidities or frailty in these patients. Data from our group suggest an inflammatory trigger for depression and potentially other psychiatric diseases and aortic valve stenosis as well as aortic valve replacement are associated with considerable changes in the inflammatory state of the patients. However, no study has prospectively examined the interaction of these inflammatory markers and mood disorders, yet. In addition, frailty is a key aspect of many of TAVR patients clinically, however, scientifically there is only emerging data with half of all PubMed-indexed publications being less than 18 months old and clinical use of various scores still under discussion.

The " Effect of interventional aortic valve replacement on emotional status, quality of life, frailty and inflammation"-study is designed to fill these gaps in evidence. It will be a prospective epidemiological cohort study to recruit 102 patients with symptomatic severe aortic valve stenosis within 18 months. All of these patients will undergo standardized cardiologic, psychiatric and frailty assessment as well as a sophisticated laboratory analysis focussing on the inflammatory state. The study aims to integrate these interdisciplinary findings to optimize patient treatment.

Conditions

• Aortic Valve Stenosis
• Clinical Trial
• Depression
• Frail Elderly Syndrome
• Inflammation

Interventions

DIAGNOSTIC_TEST

Geriatric assessment

the assessment includes functional tests (hand grip strength, SPPB (Short Physical Performance Battery)) and questionaires Euro-QoL 5D, LUTS, GDS, ADL, iADL, dietary recall).

DIAGNOSTIC_TEST

Psychiatric assessment

Psychiatric assessments includes HAMD-17 as well as Beck depression inventory, hospital anxiety and depression scale, SF36, PTSS-10

DIAGNOSTIC_TEST

Inflammatory assessment

analysis will include arginase, ADMA, SDMA, homoarginine, aminoacids + metabolites, tryptophan, kynurenine, kynurenine acid, cortisol, ACTH, Metanephrine, myeloperoxidase,

DIAGNOSTIC_TEST

Cardiological assessment

ECG, echocardiography

Sponsors & Collaborators

• Medical University of Graz

  lead OTHER

Principal Investigators

• Albrecht Schmidt, MD · Medical University of Graz

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-06

Primary Completion

2020-12-31

Completion

2020-12-31

Countries

• Austria

Study Locations