Pulse wave velocity and central aortic pressure outcomes in SPRINT

SPRINT 中的脉搏波速度和中心主动脉压结果

• 批准号: 8711543
• 负责人: Mark A Supiano
• 金额: $ 36.33万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8711543
• 关键词: Address; Age; Age-associated memory impairment; Aging; Albumins; Aldosterone; Ancillary Study; Biological Markers; Biological Preservation; Blood Pressure; Blood Vessels; Calcium; Cardiovascular system; Chronic Kidney Failure; Clinic; Clinical; Clinical Trials Design; Dementia; Disease; Event; Goals; Hemoglobin; Hemoglobin concentration result; Hormones; Hypertension; Insulin; Intervention Trial; Living Costs; Measures; Methodology; Mortality Decline; Outcome; Parathyroid gland; Parents; Patients; Peripheral; Phosphorus; Physiologic pulse; Population; Population Study; Quality of life; Randomized; Randomized Clinical Trials; Recruitment Activity; Renal function; Renin; Renin-Angiotensin-Aldosterone System; Serum; Study Subject; Testing; Time; Uric Acid; arm; blood pressure regulation; cardiovascular disorder risk; cardiovascular risk factor; clinically relevant; cognitive function; cost effectiveness; falls; fasting glucose; follow-up; glucose metabolism; insulin sensitivity; interest; peripheral blood; pressure; primary outcome; secondary outcome; therapeutic target; treatment as usual; treatment program; urinary

DESCRIPTION (provided by applicant): The Systolic Blood Pressure Intervention Trial (SPRINT) affords a unique opportunity to determine if the difference in peripheral (brachial) systolic blood pressure (SBP) that will develop between the intensive treatment group (target SBP < 120 mm Hg) and the usual care group (target SBP < 140 mm Hg) will be accompanied by significant differences in measures of vascular stiffness (aortic pulse wave velocity, aPWV) and central (aortic) BP. The overall hypothesis addressed in this SPRINT ancillary study is that measures of vascular stiffness will be predictive of the main SPRINT outcomes independent of the achieved peripheral SBP. Three primary specific aims are proposed. Specific Aim 1: To determine if aPWV (and sub-aim 1, measures of central BP) in SPRINT study subjects randomized to the intensive treatment group at year three post-randomization will be lower compared to the usual care treatment group. Specific Aim 2: To determine if the aPWV (and sub-aim 2, measures of central BP) achieved (adjusted for baseline value) in SPRINT study subjects will be an independent predictor of the primary SPRINT outcomes (CV disease events) as well as all cause mortality, decline in renal function, rate of incident dementia and age-related cognitive decline. Specific Aim 3: To determine the associations at baseline between aPWV and central BP and relevant biomarkers of vascular aging and stiffness (fasting glucose, insulin, insulin sensitivity, hemoglobin A1C, and renin and aldosterone) and markers associated with chronic kidney disease (CKD - serum calcium, phosphorous, parathyroid hormone levels, uric acid and urinary albumin). This time-sensitive ancillary study to SPRINT will add important information regarding the underlying mechanisms for vascular stiffness by assessing clinically relevant biomarkers for glucose metabolism, insulin sensitivity, the renin-angiotensin-aldosterone system, and markers associated with CKD. In addition, by collecting baseline (at randomization) and longitudinal, annual measures of vascular stiffness (aPWV) and central aortic BP using a validated, reproducible, non-invasive methodology, the value of these measures with regard to the primary SPRINT clinical outcomes will be determined. No large scale studies have addressed whether reductions in vascular stiffness per se - independent of the fall in peripheral BP - provides a better predictor of clinical benefits. Moreover, no study has assessed the change in aPWV or central aortic BP in patients treated to a target SBP of 120 mm Hg. The addition of measures of vascular stiffness will help to determine if these outcomes should be considered as a therapeutic target over and above the peripheral BP achieved. The addition of aPWV and central aortic BP measures as well as several biomarkers of vascular stiffness in this SPRINT ancillary study are therefore important scientific additions to the parent trial.

描述（由申请人提供）：收缩压干预试验（SPRINT）提供了一个独特的机会，可以确定在密集治疗组（目标SBP <120 mm HG）之间发展的周围（臂）收缩压（SBP）是否会发展出来的差异（SBP），而遇到了较大的clisesition（coverinal corlisties conferessians conferess）速度，APWV）和中央（主动脉）bp。这项Sprint辅助研究中解决的总体假设是，血管僵硬度的测量将预测与已达到的外围SBP无关的主要冲刺结果。提出了三个主要的特定目标。 具体目的1：确定与通常的护理治疗组相比，在Sprint研究对象中，Sprint研究对象将APWV（和Sub-Aim 1，中央BP的度量）随机分配给了强化治疗组。 具体目的2：确定Sprint研究受试者中实现的APWV（和Sub-Aim 2，中央BP的度量）（根据基线值调整）是否将是对主要SPRINT结果（CV疾病事件）的独立预测指标，以及所有导致死亡率，肾功能下降，肾功能下降，入射痴呆症的速度和与年龄相关的认知能力下降。 Specific Aim 3: To determine the associations at baseline between aPWV and central BP and relevant biomarkers of vascular aging and stiffness (fasting glucose, insulin, insulin sensitivity, hemoglobin A1C, and renin and aldosterone) and markers associated with chronic kidney disease (CKD - serum calcium, phosphorous, parathyroid hormone levels, uric acid and urinary albumin). 这项时间敏感的辅助研究将通过评估葡萄糖代谢，胰岛素敏感性，肾素 - 血管紧张素 - 醛固酮系统以及与CKD相关的标记来评估临床相关的生物标志物，以添加有关血管僵硬的潜在机制的重要信息。此外，通过收集基线（随机分组）和纵向，使用经过验证的，可重复的，无创方法的血管刚度（APWV）和中央主动脉BP的年度度量，将确定这些措施对主要Sprint临床临床成果的价值。 没有大规模的研究解决了血管刚度的降低本身是否与外周BP下降无关 - 可以更好地预测临床益处。此外，尚无研究评估接受为120 mm Hg的靶标SBP患者的APWV或中央主动脉BP的变化。增加血管僵硬度量的方法将有助于确定这些结果是否应被视为超出外周BP的治疗靶标。因此，在这项Sprint辅助研究中，添加APWV和中央主动脉BP测量以及几种血管刚度的生物标志物是父母试验的重要科学补充。