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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03308435
• Other study ID #: 29-371 ex 16/17
• Status: Terminated
• Start date: November 6, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2023
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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).
• Psychiatric assessment
Psychiatric assessments includes HAMD-17 as well as Beck depression inventory, hospital anxiety and depression scale, SF36, PTSS-10
• Inflammatory assessment
analysis will include arginase, ADMA, SDMA, homoarginine, aminoacids + metabolites, tryptophan, kynurenine, kynurenine acid, cortisol, ACTH, Metanephrine, myeloperoxidase,
• Cardiological assessment
ECG, echocardiography

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aortic valve area	valve area as measured calculated by doppler echocardiography	6 months
Secondary	HAMD-17 (Hamilton)	questionaire score	6 months
Secondary	BDI-II	Beck depression inventory score	6 months
Secondary	SF-36	short form-36 questionaire	6 months
Secondary	PTSS-10	Post traumatic syndrome scale-10	6 months
Secondary	Euro-QoL5D	Quality of life questionaire	6 Months
Secondary	hand grip strenght test	hand grip strenght test	6 months
Secondary	BIA	Bioelectrical impedance analysis	6 Months
Secondary	kynurenine acid	inflammatory marker	6 months