Intensive postpartum antihypertensive treatment to improve women's cardiovascular health

产后强化抗高血压治疗可改善女性心血管健康

• 批准号: 10664483
• 负责人: Anna Palatnik
• 金额: $ 21.6万
• 依托单位: MEDICAL COLLEGE OF WISCONSIN
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-01 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10664483
• 关键词: Acceleration; Adherence; Affect; Age; American Heart Association; Angiogenesis Inhibitors; Angiogenic Proteins; Antihypertensive Agents; Automobile Driving; Biological Markers; Biometry; Birth; Blood Glucose; Blood Pressure; Blood Vessels; Body mass index; Brain hemorrhage; Cardiac; Cardiovascular Diseases; Cardiovascular system; Cessation of life; Chronic; Collection; Complication; Coupled; DASH diet; Data; Diastolic blood pressure; Diet; Discipline of obstetrics; Education; Endothelium; Ensure; Event; Exposure to; Face; Femur; Future; Goals; Guidelines; Heart failure; Hypertension; Impairment; Incidence; Intervention; Knowledge; Life; Maternal-fetal medicine; Mediating; Medicine; Nature; Newly Diagnosed; Nifedipine; Not Hispanic or Latino; Participant; Patients; Pharmaceutical Preparations; Physical activity; Physiologic pulse; Pilot Projects; Postpartum Hypertension; Postpartum Period; Practice Management; Predisposing Factor; Pregnancy; Prevalence; Procedures; Process; Provider; Public Health; Randomized; Randomized, Controlled Trials; Recommendation; Recovery; Research; Risk; Sampling; Site; Sleep; Surrogate Endpoint; Testing; Tobacco Use Cessation; Variant; Vascular Diseases; Vascular Endothelial Growth Factor Receptor-1; Vascular remodeling; Woman; Work; arm; arterial stiffness; black patient; blood lipid; blood pressure control; brachial artery; cardiovascular disorder risk; cardiovascular health; design; endothelial dysfunction; feasibility testing; good diet; healthy lifestyle; hypertension control; hypertensive; improved; multidisciplinary; nicotine exposure; normotensive; nutrition; participant enrollment; pharmacologic; pilot test; postpartum morbidity; pregnancy disorder; prevent; racial disparity; recruit; reproductive; retention rate; sleep health; stem; treatment as usual; treatment guidelines; vasoconstriction

Project Abstract/Summary Hypertensive disorder of pregnancy (HDP) is a major public health problem especially postpartum. Postpartum hypertension (HTN) accounts for nearly 75% of maternal hemorrhagic strokes, heart failures, and deaths, one- third of which occurs in the first week after birth. Patients who survive these devastating complications face a lifelong sequela of cardiovascular disease (CVD). The mechanisms behind the increased risk of CVD involve vascular dysfunction generated by HDP and further exacerbated by postpartum HTN. Currently, postpartum antihypertensive treatment is recommended only for severe HTN (≥160/≥110 mmHg). There are no guidelines regarding treatment of mild HTN, defined as blood pressures (BP) of 140s-150s/90s-100s mmHg. Consequently, initiation of antihypertensive medications postpartum for mild HTN is at a provider’s discretion with a wide variation in practice. Given the prevalence and morbidity of postpartum HTN and limited research focused on how tight to control postpartum BP, it is critical to generate evidence to guide best practices for management of postpartum HTN. Our central hypothesis is that continuous exposure to HTN postpartum is a key driving factor for short-term complications of HDP and long-term risk of CVD. The overall objective of our work is to test the hypothesis that intensive BP control coupled with healthy lifestyle education can improve maternal cardiovascular health (CVH) and accelerate recovery of vascular function by limiting exposure to HTN through a large multisite randomized controlled trial (RCT). Given the complexities of conducting an RCT of this nature, the overall objective of this R34, titled “Intensive Postpartum Antihypertensive Treatment to Improve Women’s Cardiovascular Health” (IPAT) is to pilot test an RCT of pharmacological therapy for 6 weeks postpartum and healthy lifestyle education through 1 year postpartum among 60 patients with HDP. We will determine IPAT feasibility and its potential to ameliorate CVD risk following HDP. The IPAT will randomize 60 postpartum patients with HDP to intensive BP control versus usual care. Both groups will receive healthy lifestyle education on American Heart Association’s Life’s Essential 8 (LE8) CVH metrics and DASH diet by a registered dietician and a life coach. All participants will undergo vascular function assessment: endothelial dysfunction with brachial artery flow mediated dilation, arterial stiffness with carotid-femoral pulse wave velocity, and collection of an HDP-related biomarker of endothelial damage, soluble fms-like tyrosine kinase-1, at baseline (after delivery), 6 weeks, and 12 months postpartum. Aim 1 will test feasibility of all study procedures, including recruitment, retention, and adherence. Aim 2 will examine changes in BP and in LE8 CVH score from baseline to 12 months postpartum. Aim 3 will determine which vascular biomarker would be most reflective of BP control in the postpartum period. This pilot study is significant because it will answer important questions that are necessary and sufficient to establish operational feasibility and design of the larger trial that will generate evidence to guide best practices for management of postpartum HTN.

项目摘要/摘要 妊娠期高血压疾病（HDP）是一个主要的公共卫生问题，尤其是产后。产后 高血压（HTN）占孕产妇出血性中风、心力衰竭和死亡的近75%， 其中三分之一发生在出生后的第一周。在这些毁灭性的并发症中幸存下来的患者将面临 心血管疾病（CVD）的终身后遗症。CVD风险增加背后的机制包括 血管功能障碍由HDP产生，并由产后HTN进一步加剧。目前，产后 仅建议对重度HTN（≥160/≥110 mmHg）进行降压治疗。没有指导方针 关于轻度HTN的治疗，定义为血压（BP）140 s-150 s/90 s-100 s mmHg。因此，委员会认为， 轻度HTN产后是否开始使用降压药物由提供者自行决定， 实践中的变化。鉴于产后HTN的患病率和发病率以及有限的研究集中在 如何严格控制产后血压，关键是要产生证据，以指导管理的最佳做法， 产后高血压我们的中心假设是产后持续暴露于HTN是一个关键的驱动因素 HDP短期并发症和CVD长期风险。我们工作的总体目标是测试 假设强化BP控制加上健康生活方式教育可以改善孕产妇 心血管健康（CVH），并通过限制暴露于HTN来加速血管功能的恢复， 大型多中心随机对照试验（RCT）。鉴于进行这种性质的随机对照试验的复杂性， 这项R34的总体目标，题为“强化产后抗高血压治疗，以改善 妇女心血管健康”（IPAT）是一项为期6周的药物治疗随机对照试验 对60例HDP患者进行产后1年健康生活方式教育。我们将 确定IPAT的可行性及其改善HDP后CVD风险的潜力。IPAT将随机抽取60名 与常规护理相比，产后HDP患者接受强化BP控制。两组都将获得健康的生活方式 美国心脏协会的生命基本8（LE 8）CVH指标和DASH饮食的教育，由注册的 营养师和生活教练所有受试者将接受血管功能评估：内皮功能障碍， 肱动脉血流介导的扩张，动脉僵硬度与颈动脉-股动脉脉搏波速度，以及收集 在基线（分娩后）时，内皮损伤的HDP相关生物标志物，可溶性fms样酪氨酸激酶-1， 产后6周和12个月。目标1将测试所有研究程序的可行性，包括招募， 保持和粘附。目标2将检查基线至12个月期间BP和LE 8 CVH评分的变化 产后目标3将确定哪种血管生物标志物最能反映BP控制， 产后时期这项试点研究意义重大，因为它将回答一些必要的重要问题 并足以建立操作的可行性和设计的更大的试验，将产生证据，以指导 产后HTN管理的最佳实践。