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

Effect of Transfemoral Transcatheter Aortic Valve Replacement (TF-TAVR) on Emotional Status, Quality of Life, Frailty and Inflammation and Their Interactions

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.

Study Overview

• Status: Terminated
• Conditions: Depression; Inflammation; Aortic Valve Stenosis; Frail Elderly Syndrome; Clinical Trial
• Intervention / Treatment: Diagnostic test: Geriatric assessment; Diagnostic test: Psychiatric assessment; Diagnostic test: Inflammatory assessment; Diagnostic test: Cardiological assessment

Detailed Description

Aortic valve stenosis (AS) shows a high prevalence in Western civilizations with an increasing incidence and is associated with high morbidity and mortality. AS is a degenerative disease and therefore the main reason for the increasing prevalence is the higher proportion of elderly patients in western societies. Untreated symptomatic AS is characterized by severe morbidity with mainly dyspnea, orthopnea and reduced exercise capacity. In addition, AS has a very high mortality (50-90% in 2 years), most often due to lung edema as a result of increased afterload of the left ventricle. So far, there is no medical treatment available improving mortality in these patients. For decades, the only known therapy has been surgical aortic valve replacement (SAVR), having shown a dramatic reduction in mortality. However, many of the patients suffering from AS are octogenarians or even older and also suffer from multiple comorbidities. Thus, many of these patients are considered inoperable using a surgical approach. Exactly 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 12 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.

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8010
    • Medical University of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with aortic valve stenosis scheduled for transfemoral aortic valve replacement

Description

Inclusion Criteria:

• Symptomatic aortic valve stenosis
• Planned elective transcatheter aortic valve replacement
• Willingness and ability to provide signed informed consent (IC) form prior to participation in any study-related procedures

Exclusion Criteria:

• Disease reducing life expectancy to < 1 year
• Severe immune-system modulating or -affecting disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aortic valve area	valve area as measured calculated by doppler echocardiography	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HAMD-17 (Hamilton)	questionaire score	6 months
BDI-II	Beck depression inventory score	6 months
SF-36	short form-36 questionaire	6 months
PTSS-10	Post traumatic syndrome scale-10	6 months
Euro-QoL5D	Quality of life questionaire	6 Months
hand grip strenght test	hand grip strenght test	6 months
BIA	Bioelectrical impedance analysis	6 Months
kynurenine acid	inflammatory marker	6 months

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Albrecht Schmidt, MD, Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2017
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: October 7, 2017
• First Submitted That Met QC Criteria: October 11, 2017
• First Posted (Actual): October 12, 2017

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Inflammation; Aortic Valve Stenosis; Frailty
• Other Study ID Numbers: 29-371 ex 16/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: data will be shared with cooperating colleagues of the geriatric, psychiatric and laboratory departments

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No