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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

Other trials in Germany

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

  1. 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
  2. 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
  3. 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.
  4. 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.
  5. 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.
  6. 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
  7. 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
  8. 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.
  9. 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.
  10. 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.
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 groups in NCT06677528
Study groupRoleWhat they receive
Patients undergoing TAVR or SAVRNot described
Receives: Other: Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted6 Nov 2024
  2. Study start31 Jul 2024
  3. Primary completionJun 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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)
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

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.

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