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

基本信息

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
项目类别：
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

项目摘要

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：在过去二十年中，与HIV相关的心血管疾病（CVD）在低 - 收入国家。高血压（HTN）是艾滋病毒（PLWH）患者中CVD的主要驱动力。此外，plwh带有前词（前HTN），由谁定义为收缩压[SBP] 120-139 MM HG或舒张压BP [DBP] 80-89 mm Hg，CVD事件的发生率明显高于未感染 BP水平相似的成年人。尽管有可能PLWH有可能通过在较低的BP水平上启动降压治疗，他们建议PLWH应启动抗血压与没有艾滋病毒的成年人相同的BP阈值的高血压治疗。需要数据来确定使用前HTN进行CVD预防的PLWH启动降压治疗的可行性，益处和风险。我们提出了一项试点试验，以评估海地中使用前HTN的PLWH中的降压治疗。这研究将提供关键数据，该数据将为事件CVD事件提供动力的未来确定性试验。我们将招募250 PLWH（18-65岁），他们从事艺术品1 - 5年的病毒抑制和SBP 120-139 或DBP 80-89，没有降压治疗；随机将它们随机用于“早期HTN治疗”或电流护理标准（SOC）；并关注他们12个月。早期HTN治疗部门的参与者将启动氨氯地平（海地的一线降压药）立即。 SOC ARM的参与者将启动仅当氨氯地平开发HTN（SBP> 140或DBP> 90）时。我们假设早期的HTN治疗将与病毒抑制不会影响病毒性抑制，并且在12个月时BP降低，将是可行和安全的 Soc。主要目的：评估使用前HTN的PLWH中抗高血压治疗的可行性。可行性结果包括注册和保留数据，启动氨氯地平的比例和增量两臂之间12个月的SBP改变。我们具有> 80％的功率来检测SBP> 4的变化差异研究臂之间的MM HG。次要目的：还检查以下结果和措施：一个。研究臂之间的病毒抑制在12个月时（定义为HIV-1 RNA <1000份/mL） b。在6到12个月的研究臂之间比较了HIV药物的依从性 c。研究臂之间的不良事件在12个月时 d。通过与参与者和提供者的一部分进行深入的访谈评估可接受性 e。在所有参与者中衡量的CVD风险概况，包括肥胖，血脂异常，糖尿病，吸烟，身体不活跃，饮食不佳和10年CVD风险 f。在所有参与者中，使用心电图，超声心动图和血管超声