Rivera Frederick Berro, Magalong John Vincent, Bantayan Nathan Ross B, Tesoro Nicole, Milan Mark Jason, Purewal Vikramjit, Pine Polyn Luz S, Tsai Chieh-Mei, Navar Ann Marie, Mulvagh Sharon L, Januzzi James, Gibson C Michael, Lala-Trindade Anuradha, Cheng Susan, Lara-Breitinger Kyla, Guerrero Mayra, Gulati Martha
Division of Cardiology, Mayo Clinic, Rochester, Minnesota.
College of Medicine, San Beda University, Manila, Philippines.
JAMA Netw Open. 2025 Aug 1;8(8):e2529104. doi: 10.1001/jamanetworkopen.2025.29104.
IMPORTANCE: Cardiovascular (CV) disease is the leading cause of death globally for both men and women, yet women remain historically underrepresented in CV clinical trials, despite facing a disproportionately high burden of morbidity and mortality in many forms of CV disease. OBJECTIVE: To determine the representation of women across a broad range of CV trials. EVIDENCE REVIEW: The participation of women in CV trials registered on ClinicalTrials.gov from 2017 to 2023 was systematically determined through the extraction of publicly available information. Data were extracted to identify the country of study, disease type, trial size, clinical intervention, and age of the participants. The proportion of women and the ratio of number of female to male participants (F:M ratio) were calculated for each trial. The women's participation:prevalence ratio (PPR) was estimated for each trial based on the relative prevalence of the disease by sex in the specified region. FINDINGS: A total of 1079 registered CV trials were identified, including 1 396 104 participants, of whom 571 641 (41.0%) were women. The F:M ratio was significantly lower for studies on arrhythmia (median [IQR], 0.5), coronary heart disease (median [IQR], 0.39 [0.33-0.70]), acute coronary syndrome (median [IQR], 0.32 [0.24-0.51]), and heart failure (median [IQR], 0.51 [0.32-0.87]) but higher for obesity (median [IQR], 1.44 [1.08-4.50]) and pulmonary hypertension (median [IQR], 2.86 [1.50-3.97]) trials. The F:M ratio was higher for trials on lifestyle interventions (median [IQR], 1.51 [0.77-3.24]) than for drug trials. PPRs were low for clinical trials on coronary heart disease (median [IQR], 0.66 [0.50-0.86]), acute coronary syndrome (median [IQR], 0.79 [0.51-0.87]), and stroke (median [IQR], 0.74 [0.61-0.95]). Representation of women in CV trials varied by disease state, region, intervention, and sponsor type. CONCLUSIONS AND RELEVANCE: These findings highlight both progress and persistent challenges in representation of women within CV trials. These gaps not only limit the generalizability of trial outcomes but also perpetuate inequities in evidence-based care for women with CV conditions.
重要性：心血管疾病是全球男性和女性的首要死因，然而，尽管在多种形式的心血管疾病中，女性面临着不成比例的高发病率和死亡率负担，但在心血管临床试验中，女性的参与人数历来较少。 目的：确定女性在广泛的心血管试验中的参与情况。 证据综述：通过提取公开可用信息，系统地确定了2017年至2023年在ClinicalTrials.gov上注册的心血管试验中女性的参与情况。提取数据以确定研究国家、疾病类型、试验规模、临床干预措施以及参与者的年龄。计算每个试验中女性的比例以及女性与男性参与者的数量比（F:M比）。根据特定区域按性别划分的疾病相对患病率，估计每个试验的女性参与率与患病率之比（PPR）。 研究结果：共识别出1079项注册的心血管试验，包括1396104名参与者，其中571641名（41.0%）为女性。在心律失常研究（中位数[四分位间距]，0.5）、冠心病（中位数[四分位间距]，0.39[0.33 - 0.70]）、急性冠脉综合征（中位数[四分位间距]，0.32[0.24 - 0.51]）和心力衰竭（中位数[四分位间距]，0.51[0.32 - 0.87]）试验中，F:M比显著较低，但在肥胖（中位数[四分位间距]，1.44[1.08 - 4.50]）和肺动脉高压（中位数[四分位间距]，2.86[1.50 - 3.97]）试验中较高。生活方式干预试验（中位数[四分位间距]，1.51[0.77 - 3.24]）的F:M比高于药物试验。冠心病（中位数[四分位间距]，0.66[0.50 - 0.86]）、急性冠脉综合征（中位数[四分位间距]，0.79[0.51 - 0.87]）和中风（中位数[四分位间距]，0.74[0.61 - 0.95]）临床试验的PPR较低。心血管试验中女性的参与情况因疾病状态、地区、干预措施和申办者类型而异。 结论及意义：这些发现凸显了心血管试验中女性参与方面的进展和持续存在的挑战。这些差距不仅限制了试验结果的普遍性，还使患有心血管疾病的女性在循证护理方面的不平等长期存在。
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