Aortic Valve StenosisNCT03308435
Effect of TF-TAVR on Emotional Status, Quality of Life, Frailty and Inflammation
An observational study of Aortic Valve Stenosis and Clinical Trial, run by Medical University of Graz at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Clinical Trial, Depression
- What is being tested?
- Geriatric assessment, Psychiatric assessment and Inflammatory assessment
- How many people
- 18 participants
- Where
- 1 siteAustria
- Study dates
- 6 Nov 2017to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with aortic valve stenosis scheduled for transfemoral aortic valve replacement
Who may be able to join
- 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
Who cannot join
- Disease reducing life expectancy to < 1 year
- Severe immune-system modulating or -affecting disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Geriatric assessment, Psychiatric assessment, Inflammatory assessment, Cardiological assessment
- Medical subject headings
- Aortic Valve Stenosis, Depression, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric assessmentDiagnostic 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 assessmentDiagnostic test
Psychiatric assessments includes HAMD-17 as well as Beck depression inventory, hospital anxiety and depression scale, SF36, PTSS-10
Inflammatory assessmentDiagnostic test
analysis will include arginase, ADMA, SDMA, homoarginine, aminoacids + metabolites, tryptophan, kynurenine, kynurenine acid, cortisol, ACTH, Metanephrine, myeloperoxidase,
Cardiological assessmentDiagnostic test
ECG, echocardiography
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic valve area
valve area as measured calculated by doppler echocardiography
Measured: 6 months
Secondary outcomes (8)
HAMD-17 (Hamilton)
questionaire score
Measured: 6 months
BDI-II
Beck depression inventory score
Measured: 6 months
SF-36
short form-36 questionaire
Measured: 6 months
PTSS-10
Post traumatic syndrome scale-10
Measured: 6 months
Euro-QoL5D
Quality of life questionaire
Measured: 6 Months
hand grip strenght test
hand grip strenght test
Measured: 6 months
BIA
Bioelectrical impedance analysis
Measured: 6 Months
kynurenine acid
inflammatory marker
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start6 Nov 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Why it stopped: futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dirk von Lewinski, Medical University of Graz
- Investigators
- Albrecht Schmidt, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308435
- Sponsor's protocol ID
- 29-371 ex 16/17
- Status last verified
- Jan 2023
- First submitted
- 7 Oct 2017
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: data will be shared with cooperating colleagues of the geriatric, psychiatric and laboratory departments
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transfemoral Transcatheter Aortic Valve Replacement (TF-TAVR) on Emotional Status, Quality of Life, Frailty and Inflammation and Their Interactions
- ClinicalTrials.gov ID
- NCT03308435
- Acronym / sponsor ID
- 29-371 ex 16/17
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: futility
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 12 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with aortic valve stenosis scheduled for transfemoral aortic valve replacement
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Disease reducing life expectancy to < 1 year
- Severe immune-system modulating or -affecting disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geriatric assessmentthe 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 assessmentPsychiatric assessments includes HAMD-17 as well as Beck depression inventory, hospital anxiety and depression scale, SF36, PTSS-10 | Diagnostic test | – |
| Inflammatory assessmentanalysis will include arginase, ADMA, SDMA, homoarginine, aminoacids + metabolites, tryptophan, kynurenine, kynurenine acid, cortisol, ACTH, Metanephrine, myeloperoxidase, | Diagnostic test | – |
| Cardiological assessmentECG, echocardiography | Diagnostic test | – |
Primary outcome
Aortic valve area
Time frame: 6 months
valve area as measured calculated by doppler echocardiography
8 secondary outcomes
HAMD-17 (Hamilton)
Time frame: 6 months
BDI-II
Time frame: 6 months
SF-36
Time frame: 6 months
PTSS-10
Time frame: 6 months
Euro-QoL5D
Time frame: 6 Months
hand grip strenght test
Time frame: 6 months
BIA
Time frame: 6 Months
kynurenine acid
Time frame: 6 months
Results and safety
The study was stopped early (reason given: futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Individual participant dataSharing planned: Undecided. data will be shared with cooperating colleagues of the geriatric, psychiatric and laboratory departments
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Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albrecht Schmidt, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis and Clinical Trial, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: futility). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aortic valve area (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.