跳至主要内容
临床试验/NCT05357404
NCT05357404进行中(未招募)不适用

Age and Sex-Specific PREValence of AcqUirEd VALVular Heart DiseasE (PREVUE-VALVE)

Cardiovascular Research Foundation, New York1 个研究点 分布在 1 个国家目标入组 2,870 人开始时间: 2022年4月21日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
2,870
试验地点
1
主要终点
Prevalence of Valvular Heart Disease

研究概览

简要总结

The PREVUE-VALVE study will establish reliable, population-based estimates of Valvular Heart Disease (VHD) prevalence among older Americans and allow for the development and validation of several innovative tools to aid in the detection and diagnosis of Valvular Heart Disease (VHD).

详细描述

With the aging population, the incidence and prevalence of VHD are increasing in the U.S. and other parts of the developed world. Despite the availability of effective therapies and procedures to treat VHD, many patients remain (1) untreated due to undiagnosed VHD, or inadequate access to appropriate VHD care or (2) treated later than recommended due to diagnosis late in the disease course or barriers to prompt care for VHD. To optimize care for patients with VHD, it is therefore essential to (1) know the true prevalence of these conditions in order to align screening efforts with access to treatment; and (2) develop validated tools to more effectively screen and diagnose patients with VHD.

In response to these unmet needs, the PREVUE-VALVE study will establish reliable, population-based estimates of VHD prevalence in the United States and allow for the development and validation of several innovative tools to aid in the detection and diagnosis of VHD. The results of this study will enable the investigators to make tangible progress toward the goal of treating all patients with VHD at the optimal time.

The study will be conducted in a sample of older individuals (i.e., age 65-85 years) that is representative of the U.S. population. The sample will be carefully curated to ensure traditionally underrepresented individuals are included and overrepresented, if possible. After obtaining informed consent, each participant will undergo a standard echocardiogram in order to identify VHD (specifically aortic, mitral, and tricuspid valve disease) and to quantify its severity using state-of-the-art methods in a core echocardiography laboratory. Echocardiograms will be performed in participants' homes in an effort to reduce any barriers towards participation. A variety of complementary data (i.e. blood sample, electrocardiograms, and clinical inventory including a standardized health status assessment) will be collected while study personnel are with participants. Formal statistical weighting methods will be applied to estimate the population prevalence of various subtypes of VHD (e.g., aortic stenosis, mitral regurgitation) from the raw data. In addition, the investigators will report the prevalence of VHD, including VHD subtypes, and describe the association between different blood analytes and ECG characteristics with VHD.

研究设计

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

入排标准

年龄范围
65 Years 至 85 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 65-85
  • Ability to provide informed consent
  • Stably domiciled in a residence that can be accessed by study personnel

排除标准

  • History of complex congenital heart disease

结局指标

主要结局

Prevalence of Valvular Heart Disease

时间窗: Baseline

The primary endpoint of the study is the presence of any significant (i.e. moderate or greater) valvular heart disease at the baseline assessment including aortic stenosis, aortic regurgitation, mitral stenosis, mitral regurgitation, or tricuspid regurgitation.

次要结局

  • Moderate or greater mitral stenosis (at baseline)(Baseline)
  • Moderate or greater aortic stenosis (at baseline)(Baseline)
  • Moderate or greater aortic regurgitation (at baseline)(Baseline)
  • Moderate or greater tricuspid regurgitation (at baseline)(Baseline)
  • Moderate or greater mitral regurgitation (at baseline)(Baseline)

研究者

发起方
Cardiovascular Research Foundation, New York
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Age and Sex-Specific PREValence of AcqUirEd VALVular... | 临床试验