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

摘要：hiv相关心血管疾病（CVD）在过去二十年中增加了两倍

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