Valvular Heart Disease in Women Registry (VHD-W)

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.

Study Overview

• Status: Recruiting
• Conditions: Valve Disease, Heart; Guideline Adherence; Disparities; Gender Bias; Registry; Guideline Implementation

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.

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

Contacts and Locations

• Study Contact: Name: Shehab Anwer, MD; Phone Number: +41788816333; Email: shehab.anwer@gmail.com

Study Locations

• Egypt
  • Aswān, Egypt
    • Recruiting
    • Aswan Heart Centre
    • Contact: Susy Kotit, MD PhD; Phone Number: +201000000; Email: susykotit@hotmail.com
• Portugal
  • Lisbon, Portugal
    • Recruiting
    • University of Lisbon
    • Contact: Ana G Almeida, MD PhD; Phone Number: +0000000000; Email: anagalmeida@gmail.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of approximately 800 adult patients older than 18 years, with moderate-to-severe valvular heart disease (VHD) who can provide the necessary consent according to the regional/local ethical and regulatory requirements. Patients are recruited from more than 70 centers across 32 countries in Europe, America, Africa, and Australia, ensuring a diverse cohort. Eligibility includes any subtype of VHD, regardless of prior interventions, as long as the admission (urgent or elective) to a VHD-W Registry collaborating center is for management of their VHD. Collaborating Centers were invited directly by the VHD-W executive committee, supplemented by social media promotion through professional healthcare networks to encourage collaboration with centres of excellence around the globe.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Women with Valvular Heart Disease
Men with Valvular Heart Disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disparities in Valvular Heart Disease (VHD) Treatment	Assess disparities in evidence-based VHD treatments (medical, interventional or surgical management) by gender, in relation to age, ethnicity, and location. Quantify using odds ratios (OR) or relative risks (RR) with 95% CI; adjust via multivariable logistic regression. Time Frame: Baseline to 12 months post-enrollment. Analysis Plan: Chi-square/ANOVA for unadjusted comparisons; regression for adjusted analyses (p < 0.05).	One year
Disparities in Valvular Heart Disease Management	Evaluate disparities in diagnostic testing, follow-up, and multidisciplinary care using composite scores and standardized mean differences (SMD) or hazard ratios (HR); adjust with Cox models if time-dependent. Time Frame: Baseline to 12 months post-enrollment. Analysis Plan: Generalized linear mixed model (GLMM) for clustering; power for Cohen's d > 0.3.	One year
Adherence to/Compliance with European Society of Cardiology (ESC) Guidelines for Management of Valvular Heart Disease.	Measure proportion adhering to 2021 ESC guidelines (or updates); binary/ordinal scoring with reasons for non-compliance categorized. Time Frame: Through study timepoints. Analysis Plan: Binomial proportions with 95% CI; logistic regression for predictors; detect differences.	One Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from Diagnosis to Guideline-Directed Therapy: Comparison Between Women and Men	Compare median days from diagnosis to therapy initiation (medical/intervention/surgery) by sex/gender. Time Frame: Study duration. Analysis Plan: Kaplan-Meier/log-rank; Cox HR with 95% CI.	One Year
Time from Symptom Onset to Presentation at Tertiary Center: Comparison Between Women and Men	Compare median days from symptom onset to tertiary presentation by gender. Time Frame: Study duration. Analysis Plan: Wilcoxon rank-sum; quantile regression.	One Year
Procedural Complications: Comparison Between Women and Men	Compare reported complication post-intervention quantitatively based on established criteria or occurrence of major cardiovascular events. Time Frame: Intra/Post-procedure through study duration. Analysis Plan: Chi-square/Fisher's; Poisson IRR.	One Year

Collaborators and Investigators

• Sponsor: Valvular Heart Disease in Women Registry
• Collaborators: European Association of Cardiovascular Imaging
• Investigators: Principal Investigator: Julia Grapsa, MD PhD, Harvard Medical School (HMS and HSDM); Principal Investigator: Ana G Almeida, MD PhD, Lisbon University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: September 19, 2025
• First Submitted That Met QC Criteria: September 19, 2025
• First Posted (Estimated): September 29, 2025

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: cardiovascular disease; registry; valvular heart disease; gender disparities; Guidelines adherence
• Additional Relevant MeSH Terms: Heart Diseases; Behavior; Social Behavior; Prejudice; Social Discrimination; Cardiovascular Diseases; Heart Valve Diseases; Sexism
• Other Study ID Numbers: VHD-W Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to privacy concerns under international regulations such as GDPR and HIPAA, which prioritize participant confidentiality in this multicenter, global registry. Data is pseudonymized for internal analysis only, and sharing could risk re-identification, especially across diverse jurisdictions with varying ethical requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No