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

基本信息

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
项目类别：
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

项目摘要

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/总结妊娠期高血压疾病（HDP）是一个主要的公共卫生问题，尤其是产后。高血压 (HTN) 占孕产妇出血性中风、心力衰竭和死亡的近 75%，其中之一其中三分之一发生在出生后第一周，幸存下来的患者面临着这些毁灭性并发症。心血管疾病 (CVD) 的终生后遗症 CVD 风险增加的机制涉及。 HDP 产生的血管功能障碍，并因产后 HTN 进一步加剧。目前，产后。仅建议针对严重高血压（≥160/≥110 mmHg）进行抗高血压治疗。尚无指南。关于轻度高血压的治疗，定义为检查的血压（BP）为 140 秒至 150 秒/90 秒至 100 秒毫米汞柱。对于轻度高血压，产后是否开始使用抗高血压药物由医疗服务提供者自行决定，范围广泛考虑到产后高血压的患病率和发病率以及关注的研究有限。如何严格控制产后血压，生成证据来指导管理产后血压的最佳实践至关重要我们的中心假设是，产后持续接触高血压是一个关键驱动因素。我们工作的总体目标是测试 HDP 的短期并发症和 CVD 的长期风险。假设强化血压控制加上健康的生活方式教育可以改善孕产妇的健康状况通过限制接触 HTN 来促进心血管健康 (CVH) 并加速血管功能的恢复鉴于进行这种性质的 RCT 的复杂性， R34 的总体目标，标题为“强化产后抗高血压治疗以改善女性心血管健康”（IPAT）将试点为期 6 周的药物治疗随机对照试验我们将对 60 名 HDP 患者进行产后 1 年内的健康生活方式教育。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 名患者。产后 HDP 患者接受强化血压控制与常规护理相比，两组患者都将接受健康的生活方式。由注册人士提供有关美国心脏协会 Life's Essential 8 (LE8) CVH 指标和 DASH 饮食的教育所有参与者都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、颈动脉-股动脉脉搏波速度的动脉僵硬度以及收集基线时（分娩后）HDP 相关的内皮损伤生物标志物，可溶性 fms 样酪氨酸激酶-1，目标 1 将在产后 6 周和 12 个月测试所有研究程序的可行性，包括招募、目标 2 将检查从基线到 12 个月的血压和 LE8 CVH 评分的变化。目标 3 将确定哪种血管生物标志物最能反映产后血压控制。这项试点研究意义重大，因为它将回答必要的重要问题。并足以建立更大规模试验的操作可行性和设计，从而产生指导证据管理产后高血压的最佳实践。