心力衰竭临床试验和注册表中的种族代表性:系统性审查和元分析
Cynthia L Green1, Oludamilola Aladesanmi2, Godefroy Chery3
1Department of Biostatistics & Bioinformatics, Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
Journal of the National Medical Association
|January 9, 2026
概括
黑人和代表性不足的种族/民族群体 (UREGs) 在心力衰竭 (HF) 登记中比临床试验更少. 与预期相反,HF注册表与试验相比没有改善UREG参与.
科学领域:
- 心脏病学 心脏病学
- 临床试验 临床试验
- 健康差异 在健康上的差异
背景情况:
- 代表性不足的种族和民族群体 (UREGs) 面临心力衰竭 (HF) 的不成比例负担.
- 从历史上看,UREG参与高频率临床试验的比例很低.
- 假设HF注册,具有更广泛的纳入标准,可以注册更多的UREG.
研究的目的:
- 为了比较HF临床试验中的UREG与HF注册表中的UREG比例.
- 使用系统审查和元分析来量化参与差异.
主要方法:
- 来自美国的随机对照HF试验和注册表 (2010-2019) 的系统综述.
- 搜索了PubMed和Embase,并补充了临床试验.gov.gov.
- 计算了种族群体的百分比,并进行了元分析来比较招生.
主要成果:
- 包括62个试验和15个注册;大多数报告的细粒度种族数据.
- 黑人参与者在高频率注册中占比明显低 (21.8%),低于试验 (30.4%).
- 与试验 (24.3%) 相比,非白人参与者在注册表中的代表也较少 (18.0%),尽管在统计学上并不显著.
结论:
- 与试验相比,HF注册没有显示黑人和非白人患者的纳入率更高.
- 与假设相反,黑人参与者在注册表中的代表性明显低于试验.
- 调查结果突出显示,在高频率研究中,UREG参与的差异仍然存在.
相关概念视频
01:30Heart Failure IV: Classification and Diagnostic Evaluation
313
Heart failure can be classified in various ways, with the most common classifications based on physical activity limitations, disease progression, severity, and treatment strategies.The Functional Classification of Heart Failure divides patients into four categories based on physical activity limitation due to symptom burden.Class I: Patients in this class have cardiac disease but no physical activity limitations. Ordinary activities like walking, climbing stairs, or routine tasks do not cause...
313
01:26Heart Failure Drugs: Inhibitors of Renin-Angiotensin System
915
The activation of the sympathetic nervous system and the renin-angiotensin-aldosterone system (RAAS) contributes to cardiac remodeling, and inhibiting the RAAS is a pharmacological target in heart failure management. As a result, neurohumoral modulation is a crucial treatment principle for managing heart failure. This approach involves using medications like ACE inhibitors (ACEIs), angiotensin receptor blockers (ARBs), β-blockers, mineralocorticoid receptor antagonists (MRAs), and neutral...
915
01:30Heart Failure V: Medical Management
209
Medical Management of Acute Decompensated Heart Failure (ADHF)The primary goals of therapy for patients hospitalized with acute decompensated heart failure (ADHF) include:Relieving symptomsOptimizing volume statusSupporting oxygenation and ventilationMaintaining cardiac output (CO) and end-organ perfusionIdentifying and addressing the cause of ADHFPreventing complicationsProviding patient education on factors precipitating HF exacerbationPlanning for dischargeOngoing monitoring and assessment...
209
01:26Heart Failure III: Clinical Manifestations
465
Heart failure (HF) manifests primarily as dyspnea, fatigue, and fluid retention, resulting in peripheral and pulmonary edema. Symptoms may vary depending on which ventricle is more affected, left or right.Left-Sided Heart FailureAlso known as left ventricular failure, this condition results from the left ventricle's inability to fill or eject sufficient blood into the systemic circulation. It leads to pulmonary congestion, which occurs when the left ventricle fails to eject blood effectively...
465
01:17Pathophysiology of Heart Failure
2.8K
Heart failure (HF) is a progressive syndrome involving ventricles that leads to inadequate cardiac output. It can be classified based on location and output or ejection fraction. Ejection fraction (EF) is an essential measurement in the diagnosis and surveillance of HF. Reduced EF corresponds to systolic heart failure (HFrEF). However, HF with preserved ejection fraction (HFpEF) is becoming increasingly prevalent. Also known as diastolic HF, this form of HF is related to aging. The...
2.8K
01:27Heart Failure I: Introduction
676
Heart failure refers to a clinical syndrome caused by structural or functional cardiac disorders that prevent the heart from pumping an adequate amount of blood to meet the body's metabolic needs. This condition often arises from myocardial infarction or ischemia, leading to decreased cardiac output, reduced tissue perfusion, impaired gas exchange, fluid volume imbalance, and decreased functional ability.Heart failure can result from disruptions in the mechanisms that regulate cardiac output...
676