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A Mechanistic Trial of Dietary Sodium Reduction on Vascular Structure and Function in African Americans

膳食钠减少对非裔美国人血管结构和功能的机制试验

基本信息

批准号：
10365668
负责人：
Katherine Teresa Mills
金额：
$ 68.68万
依托单位：
TULANE UNIVERSITY OF LOUISIANA
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-01-17 至 2026-12-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10365668
关键词：
Academy Adherence African American African American population Albuminuria Ambulatory Blood Pressure Monitoring Area Behavior Therapy Blood Pressure Blood Vessels Cardiac Cardiovascular Diseases Cardiovascular system Chronic Disease Chronic Kidney Failure Clinic Visits Clinical Cohort Studies Control Groups Diet Dietary Sodium Dietitian Disease Outcome EFRAC Endothelium Etiology Event Exclusion Criteria Heart Heart Atrium Hour Hypertension Impairment Incidence Intake Intention Intervention Knowledge Left Left Ventricular Ejection Fraction Left Ventricular Hypertrophy Left Ventricular Mass Measures Mediating Medicine Monitor Observational Study Organ Outcome Outcome Study Participant Patients Physiologic pulse Play Potassium Protocols documentation Quality Control Randomized Randomized Controlled Trials Recording of previous events Reporting Risk Factors Role Side Sodium Standardization State Medicine Structure Testing Ventricular Woman aged arterial stiffness blood pressure elevation blood pressure reduction cardiac magnetic resonance imaging cardiovascular disorder prevention cardiovascular disorder risk cardiovascular risk factor clinical risk clinically significant dietary endothelial dysfunction high risk improved indexing men mortality primary outcome recruit renal damage secondary analysis targeted biomarker

项目摘要

Project Summary High dietary sodium intake increases risk of cardiovascular disease (CVD) independent of established risk factors, including blood pressure (BP). Non-BP mediated mechanisms underlying the increased risk of CVD associated with dietary sodium intake are not well understood, but observational studies suggest direct target organ damage in the heart and vasculature might play an important role. Little evidence exists from randomized controlled trials (RCTs) on target organ effects of dietary sodium reduction, and the National Academy of Medicine has recommended future research to “test the effects of different sodium intake levels on endothelial and vascular function” in order to “to better characterize the relationship between sodium intake and chronic disease”. Further, no RCTs have been powered to test the effect of dietary sodium reduction on subclinical cardiovascular structure and function in African Americans, who are more sensitive to dietary sodium intake and at higher risk for CVD. The overall objective of the proposed mechanistic trial is to test the effect of dietary sodium reduction on cardiac and vascular structure and function. Specifically, the proposed trial will test whether dietary sodium reduction (targeting a dietary sodium intake of <2,300 mg/day) will improve left ventricular mass index (LVMI), left ventricular global longitudinal strain (LVGLS), carotid-femoral pulse wave velocity (cfPWV), and flow-mediated dilation (FMD) compared to usual intake. Additionally, we will test whether this effect is independent from BP reduction. We will recruit 240 African Americans with elevated BP or hypertension from the greater New Orleans area and randomly assign them to a dietitian-led behavioral intervention aimed at decreasing dietary sodium intake to <2,300 mg/day for 12 months or to a usual diet. Study outcomes, including cardiac magnetic resonance imaging (CMR)-determined LVMI and LVGLS, cfPWV, and FMD, will be measured at baseline, 6-month, and 12-month clinic visits using standardized protocols with stringent quality control. These outcomes are validated biomarkers for target organ damage and predict the risk of clinical CVD events. In primary analyses, the effect of sodium reduction on each subclinical CVD endpoint will be compared between the sodium reduction and usual diet groups according to the intention-to- treat principle without adjusting for covariates. In secondary analyses, changes in ambulatory and clinical BP will be adjusted to assess the BP-independent effect of dietary sodium reduction on each subclinical CVD endpoint. The proposed trial has 85% statistical power to detect a clinically significant difference in changes of the four co-primary outcomes (10 g/m2 in LVMI, 1.3% in LVGLS, 0.9 m/s in cfPWV, and 1.1% in FMD) over 12 months between the two groups at a 2-sided significance level of 0.0125 (0.05/4). This study is the first RCT to test the effect of dietary sodium reduction on subclinical CVD endpoints in African Americans. Findings from this trial will fill the knowledge gap of the underlying mechanisms of dietary sodium intake on CVD risk and provide further evidence on sodium reduction for CVD prevention.

项目概要高膳食钠摄入量会增加心血管疾病 (CVD) 的风险，与既定风险无关因素，包括血压（BP）。非 BP 介导的 CVD 风险增加的机制与膳食钠摄入量之间的关系尚不清楚，但观察性研究表明直接目标心脏和脉管系统的器官损伤可能发挥重要作用。几乎没有证据表明关于膳食钠减少的靶器官影响的随机对照试验 (RCT)，以及国家医学科学院建议未来进行研究“测试不同钠摄入量对健康的影响” 内皮和血管功能”，以便“更好地表征钠摄入量之间的关系和慢性病”。此外，还没有随机对照试验来测试饮食中减少钠摄入对健康的影响。对饮食更敏感的非裔美国人的亚临床心血管结构和功能钠摄入量增加，患 CVD 的风险更高。所提议的机械试验的总体目标是测试膳食钠减少对心脏和血管结构和功能的影响。具体来说，拟议的试验将测试膳食钠减少（目标膳食钠摄入量<2,300毫克/天）是否会改善左心室质量指数（LVMI）、左心室整体纵向应变（LVGLS）、颈动脉-股动脉与平常摄入量相比，脉搏波速度（cfPWV）和血流介导的扩张（FMD）。此外，我们将测试这种效果是否与血压降低无关。我们将招募 240 名具有高学历的非裔美国人来自大新奥尔良地区的血压或高血压，并将其随机分配给营养师主导的行为组干预措施的目的是在 12 个月内将膳食钠摄入量减少至 <2,300 毫克/天，或保持正常饮食。研究结果，包括心脏磁共振成像 (CMR) 确定的 LVMI 和 LVGLS、cfPWV、和 FMD，将使用标准化方案在基线、6 个月和 12 个月的临床就诊时进行测量严格的质量控制。这些结果是靶器官损伤的经过验证的生物标志物，并可以预测临床CVD事件的风险。在初步分析中，钠减少对每种亚临床 CVD 的影响将根据意向对减钠组和常规饮食组之间的终点进行比较处理原则而不调整协变量。在二次分析中，动态血压和临床血压的变化将进行调整，以评估膳食钠减少对每种亚临床 CVD 的独立于血压的影响端点。拟议的试验有 85% 的统计功效可以检测到临床上显着的变化超过 12 项的四个共同主要结果（LVMI 为 10 g/m2、LVGLS 为 1.3%、cfPWV 为 0.9 m/s、FMD 为 1.1%）两组之间的个月差异，双侧显着性水平为 0.0125 (0.05/4)。这项研究是第一个随机对照试验测试膳食钠减少对非裔美国人亚临床 CVD 终点的影响。调查结果来自该试验将填补膳食钠摄入量对 CVD 风险的潜在机制的知识空白为减少钠摄入以预防心血管疾病提供进一步的证据。