Adjunct vitamin D therapy as a means to reduce the disparity in subclinical targe

辅助维生素 D 治疗是减少亚临床目标差异的一种手段

• 批准号: 8390438
• 负责人: Phillip David Levy
• 金额: $ 35.53万
• 依托单位: WAYNE STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-05-14 至 2015-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8390438
• 关键词: Accident and Emergency department; Adverse event; Affect; African American; Ambulatory Care; Antihypertensive Agents; Australia; Blood Pressure; Blood Vessels; Body Surface Area; Brain; Cardiac; Cardiovascular Diseases; Cardiovascular system; Cholecalciferol; Chronic; Clinical Trials; Communities; Data; Devices; Disease; Event; Extracellular Matrix; Fibrosis; Gadolinium; Heart; Heart Diseases; Heart Hypertrophy; Hormones; Hypertension; Hypertrophy; Individual; Injury; Institution; Intervention; Lead; Left; Left Ventricular Hypertrophy; Left Ventricular Mass; Life; Magnetic Resonance; Magnetic Resonance Imaging; Measurement; Measures; Medical; Myocardial; Myocardium; Organ; Outcome; Parathyroid gland; Patient Recruitments; Patients; Peripheral; Placebo Control; Placebos; Race; Randomized; Recording of previous events; Refractory; Relative (related person); Research; Resistance; Risk; Secondary Prevention; Secondary to; Serum Markers; Subgroup; Testing; Therapeutic; Therapeutic Agents; Therapeutic Intervention; Ventricular; Vitamin D; Vitamin D Deficiency; arm; base; blood pressure regulation; burden of illness; cardiovascular disorder risk; clinical practice; cohort; cost effective; design; disorder prevention; electric impedance; experience; gadolinium oxide; high reward; high risk; hypertension control; hypertensive heart disease; improved; indexing; inner city; insight; outcome forecast; pressure; prospective; public health relevance; pulse pressure wave; racial difference; randomized trial; response; safety net; screening; tonometry

DESCRIPTION (provided by applicant): Tremendous disparities are known to exist in cardiovascular disease and its related outcomes. Much of this can be traced to poorly controlled hypertension and its attendant, pressure-related consequences, especially target-organ cardiac damage. The latter, which occurs prematurely and disproportionately in African- Americans, reduces both quality and quantity of life. The risk of target-organ cardiac damage is particularly high among inner-city African-Americans with hypertension, particularly those who utilize the emergency department for chronic blood pressure management. Like cardiovascular disease, vitamin D deficiency disproportionately affects African-Americans. Vitamin D is thought to be an important modifier of cardiovascular disparities through its direct (and, via parathyroid hormone, indirect) myocardial (hypertrophy, fibrosis) and vascular (increased resistance, loss of compliance) effects. Vitamin D repletion in those who are deficient has been postulated as mechanism to reduce the cardiovascular disease burden experienced by African- Americans, especially if initiated early before irreversible damage has occurred, but this has yet to be tested in a prospective clinical trial. Accordingly, this proposal was designed to investigate the relationship between vitamin D and subclinical target-organ cardiac damage (as identified on cardiac magnetic resonance imaging) in a cohort of African-American, vitamin D deficient hypertensive patients without prior history of heart disease. Specifically, we seek to ascertain the effect of adjunct vitamin D therapy on left ventricular hypertrophy (primary aim), myocardial fibrosis and central vascular function (secondary aims) at one-year using a placebo controlled, randomized design. Antihypertensive treatment in both study arms will be standardized and our focus will be recruitment of patients who present to our safety-net institution with poorly controlled blood pressure - a high-risk, high-reward subset who would stand to benefit tremendously from identification of an inexpensive intervention, which could effectively reduce the adverse impact of hypertension.

描述（由申请人提供）：已知心血管疾病及其相关结果存在巨大差异。这在很大程度上可以追溯到高血压控制不善及其随之而来的与压力相关的后果，尤其是靶器官心脏损伤。后者在非裔美国人中过早且不成比例地发生，降低了生活质量和数量。在市中心患有高血压的非裔美国人中，靶器官心脏损伤的风险特别高，尤其是那些利用急诊室进行慢性血压管理的人。与心血管疾病一样，维生素 D 缺乏症对非裔美国人的影响尤为严重。维生素 D 通过其直接（以及通过甲状旁腺激素间接）心肌（肥大、纤维化）和血管（阻力增加、顺应性丧失）作用，被认为是心血管差异的重要调节剂。维生素 D 缺乏者的补充被认为是减少非裔美国人心血管疾病负担的机制，特别是如果在不可逆转的损害发生之前尽早开始补充，但这尚未在前瞻性临床试验中进行测试。因此，该提案旨在研究一组非裔美国人维生素 D 缺乏、既往无心脏病史的高血压患者中维生素 D 与亚临床靶器官心脏损伤（通过心脏磁共振成像确定）之间的关系。具体来说，我们试图使用安慰剂对照、随机设计来确定辅助维生素 D 治疗一年后对左心室肥厚（主要目标）、心肌纤维化和中枢血管功能（次要目标）的效果。两个研究组的抗高血压治疗都将标准化，我们的重点将是招募那些在我们的安全网机构中血压控制不佳的患者——这是一个高风险、高回报的子集，他们将从廉价的干预措施中获益匪浅，这可以有效减少高血压的不利影响。