Valvular Heart Disease in Women Registry

NCT ID: NCT07196930

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2030-12-31

Brief Summary

Valvular heart disease (VHD) is a major global health issue. Untreated rheumatic heart disease persists in many regions, preventable with timely care. Higher-income countries face rising calcific valve disease from aging, worsened by VHD complications, like infective endocarditis, resulting in higher morbidity/mortality. Gender disparities in VHD remains understudied, despite inequalities in risks, diagnosis, and treatment. Prevalence varies by gender, but uneven diagnostics and therapies obscure realities. This registry will examine gender disparities from hospital admission to first outpatient follow-up, recruiting both men and women to investigate and report the study objectives.

Detailed Description

Valvular heart disease (VHD) is a major global public health problem (1). Many regions of the world continue to grapple with the adverse consequences of untreated rheumatic heart disease, a condition that is largely preventable with timely access to diagnosis and treatment (2, 3). In turn, middle- and high-income countries have experienced a rise in the prevalence of calcific aortic and mitral disease, owing in part to population ageing (3). This public health problem is further compounded by high rates of infective endocarditis, which is associated with substantial morbidity and mortality. Yet, considerations of gender disparities have not taken centre stage in VHD research. This is despite evidence of major healthcare disparities in socioeconomic and medical risk factors, access to diagnosis, and provision of appropriate treatment (4-7). The prevalence of VHD varies by gender, but diagnostic evaluations are not equitable across the groups, which makes the true prevalence less clear. The delivery of evidence-based treatments for VHD is not equitable (8). The aim of this registry will be to examine gender differences in VHD from the time point of admission to the hospital (either elective or urgent admission) up to the first follow-up in an outpatient clinic. We will recruit both men and women in order to analyse the gender disparities.

Conditions

Valve Disease, Heart; Gender Bias; Guideline Adherence; Guideline Implementation; Disparities; Registry

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

Women with Valvular Heart Disease

Women with Valvular Heart Disease

No interventions assigned to this group

Men with Valvular Heart Disease

Men with Valvular Heart Disease

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Adult patients with diagnosis of any VHD according to the current ESC guidelines.
• Admission to the VHD-W Registry collaborating center.

Exclusion Criteria

• Age less than 18 years old.
• Inability to provide informed consent per local institutional and regulatory requirements.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Association of Cardiovascular Imaging

OTHER

Sponsor Role: collaborator

Valvular Heart Disease in Women Registry

NETWORK

Sponsor Role: lead

Responsible Party

Julia Grapsa

Professor, Cardiovascular Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julia Grapsa, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard Medical School (HMS and HSDM)

Ana G Almeida, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Lisbon University

Locations

Aswan Heart Centre

Aswān, , Egypt

Site Status: RECRUITING

University of Lisbon

Lisbon, , Portugal

Site Status: RECRUITING

Countries

Egypt; Portugal

Central Contacts

Shehab Anwer, MD

Role: CONTACT

shehab.anwer@gmail.com

+41788816333

Facility Contacts

Susy Kotit, MD PhD

Role: primary

susykotit@hotmail.com

+201000000

Ana G Almeida, MD PhD

Role: primary

anagalmeida@gmail.com

+0000000000

Other Identifiers

VHD-W Registry

Identifier Type: -

Identifier Source: org_study_id