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

摘要：在过去的二十年里，艾滋病毒相关心血管疾病(CVD)的发病率增加了两倍。 收入国家。高血压(HTN)是艾滋病毒携带者(PLWH)心血管疾病的主要驱动力。 此外，伴有高血压前期(HTN前)的PLWH被WHO定义为收缩压[SBP]120-139 毫米汞柱或舒张压80-89毫米汞柱，心血管事件的发生率明显高于未感染患者 血压水平相近的成年人。尽管PLWH有可能通过以下方式降低他们的心血管疾病风险 在较低的血压水平下开始降压治疗，世卫组织建议PLWH应该开始抗高血压治疗 高血压治疗与未感染艾滋病毒的成年人的血压阈值相同。需要数据来确定 高血压合并高血压患者在HTN前开始降压治疗预防心血管疾病的可行性、益处和风险。 我们建议在海地开展一项试点试验，以评估HTN前PLWH患者的降压治疗。这 这项研究将提供关键数据，为未来针对心血管事件的最终试验提供参考。我们会 招募250名接受抗逆转录病毒治疗1-5年的PLWH(18-65岁)，他们的SBP为120-139 或DBP 80-，不接受降压治疗；随机分为“早期高血压性肾炎治疗”或目前 护理标准(SOC)；并随访12个月。早期HTN治疗臂的参与者将启动 立即使用氨氯地平(海地的一线降压药)。SOC分支的参与者将启动 氨氯地平只有在出现HTN的情况下(SBP&>140或DBP&>90)。我们假设HTN的早期治疗将会 不会影响病毒抑制，在12个月后BP降低的情况下将是可行和安全的 SoC。 主要目的：评价HTN前PLWH患者开始降压治疗的可行性。 可行性结果包括登记和保留数据、服用氨氯地平的比例和增量 两臂间隔12个月时的SBP变化。我们有80%的权力来检测SBP&gt；4的变化 学习臂之间的毫米汞柱。 次要目标：还审查以下成果和措施： A.研究组在12个月时的病毒抑制情况比较(定义为HIV-1RNA和1000拷贝/毫升) B.研究组在6个月和12个月时对艾滋病毒药物依从性的比较 C.研究组之间12个月时的不良事件比较 D.通过与部分参与者和提供者的深入面谈评估可接受性 E.在登记的所有参与者中测量的心血管疾病风险概况，包括肥胖、血脂异常、糖尿病、 吸烟、缺乏运动、不良饮食和10年心血管疾病风险 F.所有参与者在登记时使用以下方法测量先前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

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