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

NCT03308435 | Terminated

• 1 other identifier: 29-371 ex 16/17
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Aortic valve area

  valve area as measured calculated by doppler echocardiography

  6 months

Secondary Outcomes (8)

• HAMD-17 (Hamilton)

  6 months

• BDI-II

  6 months

• SF-36

  6 months

• PTSS-10

  6 months

• Euro-QoL5D

  6 Months

Interventions

Geriatric assessment DIAGNOSTIC_TEST

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

Psychiatric assessment DIAGNOSTIC_TEST

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

Inflammatory assessment DIAGNOSTIC_TEST

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

Cardiological assessment DIAGNOSTIC_TEST

ECG, echocardiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with aortic valve stenosis scheduled for transfemoral aortic valve replacement

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, 8010, Austria

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum and blood cells will be collected

MeSH Terms

Conditions

Aortic Valve Stenosis; Depression; Inflammation

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Albrecht Schmidt, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: October 7, 2017
• First Posted: October 12, 2017
• Study Start: November 6, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 11, 2023

Record last verified: 2023-01

Locations

AU (1)