Aortic StenosisAWARENCT06677528
Gender-specific Evaluation of Symptom Awareness in Female Versus Male Patients with Severe Aortic Stenosis
An observational study of Aortic Stenosis and Female, run by Heart and Diabetes Center North-Rhine Westfalia at 2 sites in Germany.
Trial summary
The objectives of this single center cross-sectional cohort study are to compare symptoms and disease perception of male and female patients with severe aortic stenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Female, Male
- What is being tested?
- Questionnaire
- How many people
- 800 participants
- Where
- 2 sitesGermany
- Study dates
- 31 Jul 2024to Dec 2025
- 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: About n=800 Patients who are admitted for surgical or interventional replacement of aortic stenosis complete the following questionnaires: 1. HADS - D 2. SCL - 27 3. MLHFQ 4. Demographic data 5. AWARE - Symptoms of aortic stenosis
Who may be able to join
- • Indication for surgical or interventional aortic valve replacement for aortic stenosis as consented by the local heart team
- Age\> 18 years
- Patient is willing and able to complete the surveys in German language
Who cannot join
- • Additional procedures such as coronary bypass surgery, any surgery on another than the aortic valve, aortic surgery
- PCI performed within the last 30 days
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW
Bad Oeynhausen, 32545
Clinic for Thoracic and Cardiovascular Surgery, Herz- und Diabeteszentrum NRW
Bad Oeynhausen, 32545
About this study
The objectives of this single center cross-sectional cohort study are to compare symptoms and disease perception of male and female patients with severe aortic stenosis.
Read the detailed description
Background Aortic valve stenosis is a common valvular disease that increases with age and is associated with a poor prognosis when severe (1-3). Treatment options include surgical or interventional replacement of the aortic valve . Awareness of aortic valve stenosis in the general population is low (2% in Europe) (4). Auscultation as a simple screening tool is relatively underused. This leads to a clear underdiagnosis of aortic stenosis especially in patients with only minor or no complaints. In addition, several studies show a marked gender discrepancy: women tend to be diagnosed later, checked less regularly for asymptomatic vitium, and operated on or intervened later (5-7). One possible reason for this could be gender-specific symptom perception. For example, women perceive pain more variably, sensitively, and intensely than men and report more painful conditions. Related to a possible myocardial infarction, women show a greater number of additional, ostensibly nonbreast-related pain symptoms regardless of the presence of chest pain. Both female patients and practitioners are less likely to attribute their prodromal symptoms to heart disease compared with men. Women are generally at higher risk for affective disorders (e.g., depression, anxiety disorders) than men, with greater susceptibility varying with age (8-10).
Literature
- Andell P, Li X, Martinsson A, Andersson C, Stagmo M, Zoller B, et al. Epidemiology of valvular heart disease in a Swedish nationwide hospital-based register study. Heart 2017;103:1696-1703. https://doi.org/10.1136/heartjnl-2016-310894
- Marciniak A, Glover K, Sharma R. Cohort profile: prevalence of valvular heart disease in community patients with suspected heart failure in UK. BMJ Open 2017;7:e012240. https://doi.org/10.1136/bmjopen-2016-012240
- Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart disease: a population-based study. Lancet 2006;368: 1005-1011. https://doi.org/10.1016/S0140-6736(06)69208-8.
- Gaede L, Di Bartolomeo R, van der Kley F, Elsasser A, Iung B, Mollmann H. Aortic valve stenosis: what do people know? A heart valve disease awareness survey of over 8,800 people aged 60 or over. EuroIntervention 2016;12:883-889. https://doi.org/10.4244/ EIJY16M06_02.
- Vassileva CM, McNeely C, Mishkel G, Boley T, Markwell S, Hazelrigg S. Gender differences in long-term survival of Medicare beneficiaries undergoing mitral valve operations. Ann Thorac Surg 2013;96:1367-1373. https://doi.org/10.1016/j.athoracsur. 2013.04.055 62.
- Tanguturi VK, Bhambhani V, Picard MH, Armstrong K, Wasfy JH. Echocardiographic surveillance of valvular heart disease in different sociodemographic groups. JACC Cardiovasc Imaging 2019;12:751-752. https://doi.org/10.1016/j.jcmg.2018.05.025
- Tastet L, Kwiecinski J, Pibarot P, Capoulade R, Everett RJ, Newby DE, et al. Sex-related differences in the extent of myocardial fibrosis in patients with aortic valve stenosis. JACC Cardiovasc Imaging 2020;13:699-711. https://doi.org/10.1016/j.jcmg.2019.06.014
- Pieretti S, Di Giannuario A, Di Giovannandrea R, Marzoli F, Piccaro G, Minosi P, Aloisi AM. Gender differences in pain and its relief. Ann Ist Super Sanita. 2016 Apr-Jun;52(2):184-9. doi: 10.4415/ANN_16_02_09. PMID: 27364392.
- Lichtman JH, Leifheit EC, Safdar B, Bao H, Krumholz HM, Lorenze NP, Daneshvar M, Spertus JA, D\'Onofrio G. Sex Differences in the Presentation and Perception of Symptoms Among Young Patients With Myocardial Infarction: Evidence from the VIRGO Study (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients). Circulation. 2018 Feb 20;137(8):781-790. doi: 10.1161/CIRCULATIONAHA.117.031650. PMID: 29459463; PMCID: PMC5822747.
- Faravelli C, Alessandra Scarpato M, Castellini G, Lo Sauro C. Gender differences in depression and anxiety: the role of age. Psychiatry Res. 2013 Dec 30;210(3):1301-3. doi: 10.1016/j.psychres.2013.09.027. epub 2013 Oct 2. PMID: 24135551.
- Conditions
- Aortic Stenosis, Female, Male
- Being tested
- Questionnaire
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaire on Aortic Valve Disease, HADS-D, SCL-27, MLHFQ
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing TAVR or SAVR | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaires completed
Measured: From enrollment to the end of FU at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start31 Jul 2024
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heart and Diabetes Center North-Rhine Westfalia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677528
- Sponsor's protocol ID
- HDZ-KA_022_TR
- Acronym
- AWARE
- Status last verified
- Sep 2024
- First submitted
- 5 Nov 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender-specific Evaluation of Symptom Awareness in Female Versus Male Patients with Severe Aortic Stenosis
- ClinicalTrials.gov ID
- NCT06677528
- Acronym / sponsor ID
- AWARE / HDZ-KA_022_TR
- Conditions
- Aortic Stenosis, Female, Male
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Heart and Diabetes Center North-Rhine WestfaliaUniversity, hospital or other
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 Nov 2024 (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.
The objectives of this single center cross-sectional cohort study are to compare symptoms and disease perception of male and female patients with severe aortic stenosis.
Detailed description
Background Aortic valve stenosis is a common valvular disease that increases with age and is associated with a poor prognosis when severe (1-3). Treatment options include surgical or interventional replacement of the aortic valve . Awareness of aortic valve stenosis in the general population is low (2% in Europe) (4). Auscultation as a simple screening tool is relatively underused. This leads to a clear underdiagnosis of aortic stenosis especially in patients with only minor or no complaints. In addition, several studies show a marked gender discrepancy: women tend to be diagnosed later, checked less regularly for asymptomatic vitium, and operated on or intervened later (5-7). One possible reason for this could be gender-specific symptom perception. For example, women perceive pain more variably, sensitively, and intensely than men and report more painful conditions. Related to a possible myocardial infarction, women show a greater number of additional, ostensibly nonbreast-related pain symptoms regardless of the presence of chest pain. Both female patients and practitioners are less likely to attribute their prodromal symptoms to heart disease compared with men. Women are generally at higher risk for affective disorders (e.g., depression, anxiety disorders) than men, with greater susceptibility varying with age (8-10).
Literature
- Andell P, Li X, Martinsson A, Andersson C, Stagmo M, Zoller B, et al. Epidemiology of valvular heart disease in a Swedish nationwide hospital-based register study. Heart 2017;103:1696-1703. https://doi.org/10.1136/heartjnl-2016-310894
- Marciniak A, Glover K, Sharma R. Cohort profile: prevalence of valvular heart disease in community patients with suspected heart failure in UK. BMJ Open 2017;7:e012240. https://doi.org/10.1136/bmjopen-2016-012240
- Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart disease: a population-based study. Lancet 2006;368: 1005-1011. https://doi.org/10.1016/S0140-6736(06)69208-8.
- Gaede L, Di Bartolomeo R, van der Kley F, Elsasser A, Iung B, Mollmann H. Aortic valve stenosis: what do people know? A heart valve disease awareness survey of over 8,800 people aged 60 or over. EuroIntervention 2016;12:883-889. https://doi.org/10.4244/ EIJY16M06_02.
- Vassileva CM, McNeely C, Mishkel G, Boley T, Markwell S, Hazelrigg S. Gender differences in long-term survival of Medicare beneficiaries undergoing mitral valve operations. Ann Thorac Surg 2013;96:1367-1373. https://doi.org/10.1016/j.athoracsur. 2013.04.055 62.
- Tanguturi VK, Bhambhani V, Picard MH, Armstrong K, Wasfy JH. Echocardiographic surveillance of valvular heart disease in different sociodemographic groups. JACC Cardiovasc Imaging 2019;12:751-752. https://doi.org/10.1016/j.jcmg.2018.05.025
- Tastet L, Kwiecinski J, Pibarot P, Capoulade R, Everett RJ, Newby DE, et al. Sex-related differences in the extent of myocardial fibrosis in patients with aortic valve stenosis. JACC Cardiovasc Imaging 2020;13:699-711. https://doi.org/10.1016/j.jcmg.2019.06.014
- Pieretti S, Di Giannuario A, Di Giovannandrea R, Marzoli F, Piccaro G, Minosi P, Aloisi AM. Gender differences in pain and its relief. Ann Ist Super Sanita. 2016 Apr-Jun;52(2):184-9. doi: 10.4415/ANN_16_02_09. PMID: 27364392.
- Lichtman JH, Leifheit EC, Safdar B, Bao H, Krumholz HM, Lorenze NP, Daneshvar M, Spertus JA, D\'Onofrio G. Sex Differences in the Presentation and Perception of Symptoms Among Young Patients With Myocardial Infarction: Evidence from the VIRGO Study (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients). Circulation. 2018 Feb 20;137(8):781-790. doi: 10.1161/CIRCULATIONAHA.117.031650. PMID: 29459463; PMCID: PMC5822747.
- Faravelli C, Alessandra Scarpato M, Castellini G, Lo Sauro C. Gender differences in depression and anxiety: the role of age. Psychiatry Res. 2013 Dec 30;210(3):1301-3. doi: 10.1016/j.psychres.2013.09.027. epub 2013 Oct 2. PMID: 24135551.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing TAVR or SAVR | – | Other: Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- About n=800 Patients who are admitted for surgical or interventional replacement of aortic stenosis complete the following questionnaires: 1. HADS - D 2. SCL - 27 3. MLHFQ 4. Demographic data 5. AWARE - Symptoms of aortic stenosis
Key inclusion criteria (3 listed)
- • Indication for surgical or interventional aortic valve replacement for aortic stenosis as consented by the local heart team
Key exclusion criteria (2 listed)
- • Additional procedures such as coronary bypass surgery, any surgery on another than the aortic valve, aortic surgery
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 |
|---|---|---|
| QuestionnaireQuestionnaire on Aortic Valve Disease, HADS-D, SCL-27, MLHFQ | Other | Patients undergoing TAVR or SAVR |
Primary outcome
Questionnaires completed
Time frame: From enrollment to the end of FU at 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis and Female, run by Heart and Diabetes Center North-Rhine Westfalia at 2 sites in Germany.
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: status not confirmed, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
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?
Questionnaires completed (time frame: From enrollment to the end of FU at 4 weeks). 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 6 Nov 2024.