Valvular Heart Disease in Women Registry (VHD-W)

September 19, 2025 updated by: Julia Grapsa, Valvular Heart Disease in Women Registry
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Aswān, Egypt
        • Recruiting
        • Aswan Heart Centre
        • Contact:
  • Portugal
      • Lisbon, Portugal
        • Recruiting
        • University of Lisbon
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Women with Valvular Heart Disease
Men with Valvular Heart Disease

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Disparities in Valvular Heart Disease (VHD) Treatment
Time Frame: One year
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
Time Frame: One year
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.
Time Frame: One Year
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time from Diagnosis to Guideline-Directed Therapy: Comparison Between Women and Men
Time Frame: One Year
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
Time Frame: One Year
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
Time Frame: One Year
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Valvular Heart Disease in Women Registry

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
European Association of Cardiovascular Imaging

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Julia Grapsa, MD PhD, Harvard Medical School (HMS and HSDM)
  • Principal Investigator: Ana G Almeida, MD PhD, Lisbon University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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