Gender-specific Evaluation of Symptom Awareness in Female Versus Male Patients with Severe Aortic Stenosis (AWARE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Stenosis; Female; Male
• Intervention / Treatment: Other: Questionnaire

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.

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

Study Locations

• Germany
  • Bad Oeynhausen, Germany, 32545
    • Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW
  • Bad Oeynhausen, Germany, 32545
    • Clinic for Thoracic and Cardiovascular Surgery, Herz- und Diabeteszentrum NRW

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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

Description

Inclusion Criteria:

• • 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

Exclusion Criteria:

• • Additional procedures such as coronary bypass surgery, any surgery on another than the aortic valve, aortic surgery

  • PCI performed within the last 30 days

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing TAVR or SAVR	Other: Questionnaire; Questionnaire on Aortic Valve Disease, HADS-D, SCL-27, MLHFQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Questionnaires completed	From enrollment to the end of FU at 4 weeks

Collaborators and Investigators

• Sponsor: Heart and Diabetes Center North-Rhine Westfalia

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Actual): November 6, 2024

Study Record Updates

• Last Update Posted (Actual): November 6, 2024
• Last Update Submitted That Met QC Criteria: November 5, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: HDZ-KA_022_TR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No