Valve Disease, HeartVHD-WNCT07196930
Valvular Heart Disease in Women Registry
An observational study of Valve Disease, Heart and Gender Bias, run by Valvular Heart Disease in Women Registry at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Valve Disease, Heart, Gender Bias, Guideline Adherence
- How many people
- 800 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Apr 2024to Dec 2030
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: 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.
Who may be able to join
- Adult patients with diagnosis of any VHD according to the current ESC guidelines.
- Admission to the VHD-W Registry collaborating center.
Who cannot join
- Age less than 18 years old.
- Inability to provide informed consent per local institutional and regulatory requirements.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Egypt1 site, 1 recruiting
- Recruiting
Aswan Heart Centre
Aswān
Susy Kotit, MD PhD, +201000000, susykotit@hotmail.com
Portugal1 site, 1 recruiting
- Recruiting
University of Lisbon
Lisbon
Ana G Almeida, MD PhD, +0000000000, anagalmeida@gmail.com
About this study
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.
Read the 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
- Keywords
- valvular heart disease, registry, cardiovascular disease, gender disparities, Guidelines adherence
- Medical subject headings
- Heart Valve Diseases, Sexism, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with Valvular Heart Disease | Women with Valvular Heart Disease | |
| Men with Valvular Heart Disease | Men with Valvular Heart Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: One Year
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Apr 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valve Disease, HeartStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Other
- Enrolment
- 800 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Valvular Heart Disease in Women Registry
- Sponsor type
- Research network
- Collaborators
- European Association of Cardiovascular Imaging
- Responsible party
- Principal investigator, Julia Grapsa, Valvular Heart Disease in Women Registry
- Investigators
- Julia Grapsa, MD PhD, Principal investigator, Harvard Medical School (HMS and HSDM)Ana G Almeida, MD PhD, Principal investigator, Lisbon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196930
- Sponsor's protocol ID
- VHD-W Registry
- Acronym
- VHD-W
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valvular Heart Disease in Women Registry
- ClinicalTrials.gov ID
- NCT07196930
- Acronym / sponsor ID
- VHD-W / VHD-W Registry
- Conditions
- Valve Disease, Heart, Gender Bias, Guideline Adherence, Guideline Implementation, Disparities, Registry
- Keywords
- valvular heart disease, registry, cardiovascular disease, gender disparities, Guidelines adherence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Valvular Heart Disease in Women RegistryResearch network
- Collaborators
- European Association of Cardiovascular Imaging
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with Valvular Heart Disease | – | –Women with Valvular Heart Disease |
| Men with Valvular Heart Disease | – | –Men with Valvular Heart Disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Adult patients with diagnosis of any VHD according to the current ESC guidelines.
- Admission to the VHD-W Registry collaborating center.
Key exclusion criteria (2 listed)
- Age less than 18 years old.
- Inability to provide informed consent per local institutional and regulatory requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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.
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.
3 secondary outcomes
Time from Diagnosis to Guideline-Directed Therapy: Comparison Between Women and Men
Time frame: One Year
Time from Symptom Onset to Presentation at Tertiary Center: Comparison Between Women and Men
Time frame: One Year
Procedural Complications: Comparison Between Women and Men
Time frame: One Year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julia Grapsa, MD PhD principal investigator
Harvard Medical School (HMS and HSDM)
Ana G Almeida, MD PhD principal investigator
Lisbon University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Valve Disease, Heart and Gender Bias, run by Valvular Heart Disease in Women Registry at 2 sites in 2 countries.
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 2 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: looking for participants now, as of the sponsor's last update on 29 Sep 2025. 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 Egypt, Portugal. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shehab Anwer, MD (+41788816333, shehab.anwer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disparities in Valvular Heart Disease (VHD) Treatment (time frame: One year). The study lists 3 primary outcomes in all. 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 29 Sep 2025.