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

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ClinicalTrials.gov Identifier: NCT03308435
Recruitment Status : Recruiting
First Posted : October 12, 2017
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Dirk von Lewinski, Medical University of Graz

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.


Condition or disease Intervention/treatment
Aortic Valve Stenosis Clinical Trial Depression Frail Elderly Syndrome Inflammation 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
Estimated Enrollment : 102 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Transfemoral Transcatheter Aortic Valve Replacement (TF-TAVR) on Emotional Status, Quality of Life, Frailty and Inflammation and Their Interactions
Actual Study Start Date : November 6, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  1. Aortic valve area [ Time Frame: 6 months ]
    valve area as measured calculated by doppler echocardiography


Secondary Outcome Measures :
  1. HAMD-17 (Hamilton) [ Time Frame: 6 months ]
    questionaire score

  2. BDI-II [ Time Frame: 6 months ]
    Beck depression inventory score

  3. SF-36 [ Time Frame: 6 months ]
    short form-36 questionaire

  4. PTSS-10 [ Time Frame: 6 months ]
    Post traumatic syndrome scale-10

  5. Euro-QoL5D [ Time Frame: 6 Months ]
    Quality of life questionaire

  6. hand grip strenght test [ Time Frame: 6 months ]
    hand grip strenght test

  7. BIA [ Time Frame: 6 Months ]
    Bioelectrical impedance analysis

  8. kynurenine acid [ Time Frame: 6 months ]
    inflammatory marker


Biospecimen Retention:   Samples With DNA
Plasma, serum and blood cells will be collected


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with aortic valve stenosis scheduled for transfemoral aortic valve replacement
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308435


Contacts
Contact: Dirk von Lewinski, MD +43 316 385 ext 80684 dirk.von-lewinski@medunigraz.at
Contact: Ewald Kolesnik, MD +43 316 385 ext 30044 ewald.kolesnik@medunigraz.at

Locations
Austria
Medical University of Graz Recruiting
Graz, Austria, 8010
Contact: Dirk von Lewinski    +4331638580684    dirk.von-lewinski@medunigraz.at   
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Dirk von Lewinski, MD Medical University of Graz

Responsible Party: Dirk von Lewinski, Assoc. Prof., Medical University of Graz
ClinicalTrials.gov Identifier: NCT03308435     History of Changes
Other Study ID Numbers: 29-371 ex 16/17
First Posted: October 12, 2017    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: data will be shared with cooperating colleagues of the geriatric, psychiatric and laboratory departments

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Inflammation
Aortic Valve Stenosis
Pathologic Processes
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction