跳至主要内容
临床试验/NCT07196930
NCT07196930招募中不适用

Valvular Heart Disease in Women Registry

Valvular Heart Disease in Women Registry2 个研究点 分布在 2 个国家目标入组 800 人开始时间: 2024年4月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
800
试验地点
2
主要终点
Disparities in Valvular Heart Disease (VHD) Treatment

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Disparities in Valvular Heart Disease (VHD) Treatment

时间窗: 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

时间窗: 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.

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Valvular Heart Disease in Women Registry
申办方类型
Network
责任方
Principal Investigator
主要研究者

Julia Grapsa

Professor, Cardiovascular Medicine

Valvular Heart Disease in Women Registry

研究点 (2)

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