Valvular Heart Disease in Women Registry

NCT07196930 | Recruiting DMC

• 1 other identifier: VHD-W Registry
• Study Type: observational
• Target: 800
• Locations: 2 countries
• Sites: 2

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.

Conditions

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

Keywords

valvular heart disease; registry; cardiovascular disease; gender disparities; Guidelines adherence

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Time from Diagnosis to Guideline-Directed Therapy: Comparison Between Women and Men

  One Year

• Time from Symptom Onset to Presentation at Tertiary Center: Comparison Between Women and Men

  One Year

• Procedural Complications: Comparison Between Women and Men

  One Year

Study Arms (2)

Women with Valvular Heart Disease

Women with Valvular Heart Disease

Men with Valvular Heart Disease

Men with Valvular Heart Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Valvular Heart Disease in Women Registry: lead
• European Association of Cardiovascular Imaging: collaborator

Study Sites (2)

Aswan Heart Centre

Aswān, Egypt

RECRUITING

University of Lisbon

Lisbon, Portugal

RECRUITING

MeSH Terms

Conditions

Heart Valve Diseases; Sexism; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Prejudice; Social Behavior; Behavior; Social Discrimination

Study Officials

• Julia Grapsa, MD PhD

  Harvard Medical School (HMS and HSDM)

  PRINCIPAL INVESTIGATOR

• Ana G Almeida, MD PhD

  Lisbon University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shehab Anwer, MD

CONTACT

+41788816333; shehab.anwer@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Cardiovascular Medicine

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 29, 2025
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2030
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1); EG (1)