Treatment of early hypertension in persons living with HIV for cardiovascular disease prevention in Haiti

在海地治疗艾滋病毒感染者的早期高血压以预防心血管疾病

• 批准号: 10256056
• 负责人: Margaret Leighton McNairy
• 金额: $ 16.63万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10256056
• 关键词: Adherence; Adult; Adverse event; African American; Age; Age-Years; Americas; Amlodipine; Antihypertensive Agents; Benefits and Risks; Blood Pressure; Blood Vessels; CD4 Lymphocyte Count; Cardiac Death; Cardiovascular Diseases; Cessation of life; Clinic; Data; Diabetes Mellitus; Diagnostic; Dyslipidemias; Early treatment; Echocardiography; Edema; Electrocardiogram; Enrollment; Event; Funding; Future; General Population; Guidelines; HIV; HIV-1; Haiti; Haitian; Health; Hypertension; Hypotension; Individual; Infection; Infrastructure; Interview; Measures; Multicenter Trials; Myocardial Infarction; Myocardial dysfunction; Obesity; Outcome; Outcome Measure; Participant; Peripheral; Persons; Pharmaceutical Preparations; Pilot Projects; Prevalence; Primary Health Care; Progressive Disease; Provider; RNA; Randomized; Randomized Controlled Trials; Research; Risk; Risk Factors; Smoking; Stroke; Symptoms; Time; Ultrasonography; Unhealthy Diet; United States National Institutes of Health; Universities; Vascular Diseases; Viral; antiretroviral therapy; arm; blood pressure reduction; cardiovascular disorder epidemiology; cardiovascular disorder prevention; cardiovascular disorder risk; comorbidity; diabetic; high risk population; hypertension treatment; improved; low income country; medication compliance; mortality; multidisciplinary; physical inactivity; pill; pilot trial; prehypertension; prevent; sex; standard of care; success; treatment arm; trial comparing

ABSTRACT: HIV-associated cardiovascular disease (CVD) has tripled over the past two decades in low- income countries. Hypertension (HTN) is a major driver of CVD among persons living with HIV (PLWH). Moreover, PLWH with prehypertension (pre-HTN), defined by WHO as systolic blood pressure [SBP] 120-139 mm Hg or diastolic BP [DBP] 80-89 mm Hg, have significantly higher rates of CVD events than uninfected adults with similar BP levels. Despite the possibility that PLWH could potentially reduce their CVD risks by initiating antihypertensive treatment at lower BP levels, WHO recommends that PLWH should initiate anti- hypertension treatment at the same BP threshold as adults without HIV. Data are needed to determine the feasibility, benefits and risks of initiating antihypertensive treatment in PLWH with pre-HTN for CVD prevention. We propose a pilot trial to evaluate antihypertensive treatment among PLWH with pre-HTN in Haiti. This study will provide critical data that will inform a future definitive trial powered for incident CVD events. We will enroll 250 PLWH (18-65 years) who have been on ART for 1-5 years with viral suppression and SBP 120-139 or DBP 80-89 and no antihypertensive treatment; randomize them to “early HTN treatment” or the current standard of care (SOC); and follow them for 12 months. Participants in the early HTN treatment arm will initiate amlodipine (Haiti’s first-line antihypertensive medication) immediately. Participants in the SOC arm will initiate amlodipine only if they develop HTN (SBP >140 or DBP >90). We hypothesize that early HTN treatment will not impact viral suppression and will be feasible and safe with a reduction in BP at 12 months compared to SOC. Primary Aim: To assess the feasibility of initiating antihypertensive treatment among PLWH with pre-HTN. Feasibility outcomes include enrollment and retention data, proportion who initiate amlodipine, and incremental change in SBP at 12 months between arms. We have >80% power to detect differences in change in SBP > 4 mm Hg between study arms. Secondary Aims: To also examine the following outcomes and measures: a. Viral suppression compared between study arms at 12 months (defined as HIV-1 RNA < 1000 copies/ml) b. HIV medication adherence compared between study arms at 6 and 12 months c. Adverse events compared between study arms at 12 months d. Acceptability assessed through in-depth interviews with a subset of participants and providers e. CVD risk profile measured among all participants at enrollment including obesity, dyslipidemia, diabetes, smoking, physical inactivity, poor diet, and 10-year CVD risk f. Pre-existing myocardial and vascular dysfunction measured among all participants at enrollment using ECG, echocardiography, and vascular ultrasound

摘要：过去 20 年来，低收入人群中与 HIV 相关的心血管疾病 (CVD) 增加了两倍 收入国家。高血压 (HTN) 是艾滋病毒感染者 (PLWH) 中 CVD 的主要驱动因素。 此外，患有高血压前期（pre-HTN）的 PLWH，世界卫生组织将其定义为收缩压 [SBP] 120-139 mm Hg 或舒张压 [DBP] 80-89 mm Hg，CVD 事件发生率明显高于未感染者 血压水平相似的成年人。尽管 PLWH 有可能通过以下方式降低 CVD 风险： 在血压水平较低时开始抗高血压治疗，世界卫生组织建议感染者应开始抗高血压治疗 高血压治疗的血压阈值与未感染艾滋病毒的成年人相同。需要数据来确定 PLWH 开始抗高血压治疗并预防 CVD 的可行性、益处和风险。 我们提议进行一项试点试验，以评估海地 PLWH 接受高血压前治疗后的抗高血压治疗。这 研究将提供关键数据，为未来针对突发CVD事件的最终试验提供信息。我们将 招募 250 名 PLWH（18-65 岁），他们已接受 ART 1-5 年，病毒抑制且 SBP 120-139 或 DBP 80-89 且未接受抗高血压治疗；将他们随机分配到“早期 HTN 治疗”或当前治疗 护理标准（SOC）；并跟踪他们 12 个月。早期 HTN 治疗组的参与者将开始 立即服用氨氯地平（海地的一线抗高血压药物）。 SOC 部门的参与者将发起 仅当患者出现高血压（SBP >140 或 DBP >90）时才使用氨氯地平。我们假设早期 HTN 治疗将 不会影响病毒抑制，并且与 12 个月时相比可行且安全，血压降低 SOC。 主要目的：评估在 PLWH 中使用 pre-HTN 开始抗高血压治疗的可行性。 可行性结果包括注册和保留数据、开始使用氨氯地平的比例以及增量 各组间 12 个月时收缩压的变化。我们有 >80% 的能力来检测 SBP 变化的差异 > 4 研究臂之间的毫米汞柱。 次要目标：还检查以下成果和措施： 一个。 12 个月时研究组之间的病毒抑制比较（定义为 HIV-1 RNA < 1000 拷贝/ml） b.比较研究组在 6 个月和 12 个月时的 HIV 药物治疗依从性 c. 12 个月时研究组之间的不良事件比较 d.通过对一部分参与者和提供者进行深入访谈来评估可接受性 e.所有参与者在入组时测量的 CVD 风险状况包括肥胖、血脂异常、糖尿病、 吸烟、缺乏运动、不良饮食和 10 年 CVD 风险 f.使用以下方法测量所有参与者在入组时预先存在的心肌和血管功能障碍： 心电图、超声心动图和血管超声