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 高血压妊娠（HDP）是一个主要的公共卫生问题，尤其是产后。产后 高血压（HTN）占产妇出血性中风，心脏衰竭和死亡的近75％ 其中第三个发生在出生后的第一周。幸存这些毁灭性并发症的患者面临 心血管疾病（CVD）的终身后遗症。 CVD风险增加背后的机制涉及 HDP产生的血管功能障碍并进一步由产后HTN加剧。目前，产后 建议仅针对严重的HTN（≥160/≥110mmHg）进行降压治疗。没有准则 考虑对轻度HTN的处理，定义为140S-150S/90S-100S MMHG的血压（BP）。最后， 在轻度HTN的产后启动降压药，由提供者酌情决定 实践中的变化。鉴于产后HTN的患病率和发病率和有限的研究重点是 控制产后BP多么紧密，至关重要的是，生成证据以指导管理的最佳实践 产后HTN。我们的中心假设是，连续暴露于HTN产后是关键驱动因素 HDP的短期并发症和CVD的长期风险。我们工作的总体目标是测试 假设强化BP控制以及健康的生活方式教育可以改善母亲 心血管健康（CVH）和通过限制暴露于HTN的血管功能的恢复 大型多站点随机对照试验（RCT）。考虑到进行这种性质的复杂性， R34的总体目标，标题为“强化产后降压治疗以改善 妇女心血管健康”（IPAT）是为了测试6周的药物治疗RCT 在60例HDP患者中，产后1年，产后和健康的生活方式教育。我们将 确定IPAT可行性及其在HDP后改善CVD风险的潜力。 IPAT将随机化60 产后HDP患者进行强化BP控制与通常的护理。两组将获得健康的生活方式 关于美国心脏协会生命的基本8（LE8）CVH指标和破折号的教育 营养师和生活教练。所有参与者将接受血管功能评估：内皮功能障碍 肱动脉流介导的词典，颈动脉脉搏波速度的动脉刚度以及收集 内皮损伤的HDP相关生物标志物，固体FMS样酪氨酸激酶-1，基线后（输送后）， 产后6周和12个月。 AIM 1将测试所有研究程序的可行性，包括招聘， 保留和依从性。 AIM 2将检查BP和LE8 CVH分数的变化从基线到12个月 产后。 AIM 3将确定哪种血管生物标志物最反射的BP控制 产后期。这项试点研究很重要，因为它将回答必要的重要问题 足以建立大型试验的运营可行性和设计，这将产生证据以指导 产后HTN管理的最佳实践。