Effect of Prophylactic Treatment With Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis Patients.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Change in Pulse Wave Velocity (PWV)
研究概览
简要总结
This study evaluates the effect in artery stiffness of enalapril maleate in Rheumatoid Arthritis women patients. Half of participants will receive 5 mg enalapril maleate every 12 hrs, while the other half will receive a placebo.
详细描述
Rheumatoid Arthritis (RA) is a chronic inflammatory systemic disease considered as an independent cardiovascular risk factor that is associated with cumulative inflammatory load with an elevation of circulating levels of cytokines, which mediate the mechanism of endothelial cells activation by increasing the angiotensin converting enzyme (ACE) function and generation of vasoconstriction. Enalapril maleate is a prodrug that is hydrolyzed by hepatic esterases in enalaprilat, which is a potent inhibitor of ACE. ACE inhibition decreases vascular systemic resistance and mean, diastolic and systolic blood pressures in several hypertensive states, independently of the mechanism, ACE inhibitors have a widespread clinic use for cardiovascular diseases. Therefore, the researchers considered that there could be an association between the use of enalapril and the decrease in arterial stiffness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participant, care provider, investigator and outcomes assessor.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients classified with RA according to the American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) 2010
- •Patients treated in the outpatient service of the Rheumatology Service of the Hospital Civil de Guadalajara "Dr. Juan I Menchaca".
- •Sign an Informed Consent Letter
- •Under treatment with conventional Disease-Modifying Antirheumatic Drugs (DMARDS)
排除标准
- •Patients with a previous diagnosis of diabetes mellitus, systemic hypertension, thyroid, kidney or liver disease
- •History of acute myocardial infarction, cardiac arrhythmias, cerebral vascular event or heart failure
- •Smoking active patients in the last 6 months
- •Patients with a desire for close conception, pregnant or breastfeeding.
- •Patients with blood pressure <90/60 mmHg
- •Patients who do not accept to participate in the study
- •Patients with a BMI greater than ≥40 Kg / m2
- •Non-palpable carotid and femoral pulses
- •Unstable psychological state
研究组 & 干预措施
Enalapril Maleate
Enalapril Maleate 5 mg every 12 hrs for 90 days.
干预措施: Enalapril Maleate (Drug)
Placebo
Substance that lacks in itself therapeutic action.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Pulse Wave Velocity (PWV)
时间窗: Baseline and 90 days
This is a measure of arterial stiffness, or the rate at which pressure waves move down the vessel.
次要结局
- Change in Cardio-Ankle Vascular Index(Baseline and 90 days)
研究者
Mónica VázquezdelMercadoEspinosa
PhD
University of Guadalajara