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首页> 外文期刊>Trials >Addition of Propranolol in Resistant Arterial hypertension Treatment (APROPRIATE study): study protocol for a randomized double-blind placebo-controlled trial
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Addition of Propranolol in Resistant Arterial hypertension Treatment (APROPRIATE study): study protocol for a randomized double-blind placebo-controlled trial

机译：普萘洛尔在抗高血压治疗中的应用（适当的研究）：一项随机双盲安慰剂对照试验的研究方案

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Background Resistant hypertension is defined as an uncontrolled blood pressure despite treatment at best-tolerated doses with at least three antihypertensive agents including a diuretic. It is an emerging public health problem. At present clinical trial data on management of resistant hypertension is limited. Management is largely based on observational studies and expert opinions. Propranolol is a nonselective beta blocker. Several studies have confirmed that propranolol has a significant hypotensive action, both when used alone and as an adjuvant therapy. At present there are no prospective, randomized, clinical studies evaluating the effectiveness of propranolol in patients with resistant hypertension. Therefore, we have designed a prospective randomized trial to evaluate the safety and efficacy of propranolol in patients with resistant hypertension. Methods/design The study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for a period of 3?months. The study has been approved by the Ethics Review Committee of the Faculty of Medicine, University of Colombo. A total of 200 adults with resistant hypertension will be recruited for the study. They will be randomly assigned to the test and placebo groups on a 1:1 ratio. The test group will receive propranolol 40?mg three times a day and the control group will receive an identical placebo capsule. The study drugs will be double blinded to both investigators and subjects. The visits and the evaluations will be done as follows: screening (visit 0), 1?month (visit 1), 2?months (visit 2) and 3?months (visit 3). The primary outcomes of the study is to find a statistically significant difference between the fall in mean systolic and mean diastolic blood pressure measured by ABPM (ambulatory blood pressure monitoring) from baseline between the two groups. Data will be analyzed using SPSS v16. Discussion To our knowledge this is one of the first randomized controlled trials evaluating the effects of propranolol in resistant hypertension. This study will provide the necessary groundwork for future large-scale, multicentered clinical trials. The result, positive or negative, should provide a step change in the evidence guiding current and future policies regarding treatment of resistant hypertension. Trial registration Sri Lanka Clinical Trials Registry, identifier: SLCTR/2016/002 . Registered on 27 January 2016; Study protocol version 2.1.
机译：背景抵抗性高血压定义为尽管使用了至少三种抗高血压药（包括利尿剂）以最佳耐受剂量进行治疗，但血压仍未得到控制。这是一个新兴的公共卫生问题。目前关于抗高血压治疗的临床试验数据有限。管理主要基于观察研究和专家意见。普萘洛尔是一种非选择性β受体阻滞剂。几项研究已经证实，普萘洛尔单独使用或作为辅助疗法均具有显着的降压作用。目前，尚无前瞻性，随机，临床研究评估普萘洛尔在耐药性高血压患者中的有效性。因此，我们设计了一项前瞻性随机试验，以评估普萘洛尔在耐药性高血压患者中的安全性和有效性。方法/设计该研究将作为一项随机，双盲，安慰剂对照的临床试验进行，为期3个月。该研究已经科伦坡大学医学院伦理审查委员会批准。总共将招募200位抵抗性高血压的成年人参加研究。他们将以1：1的比例随机分配到测试组和安慰剂组。试验组一天三次接受普萘洛尔40mg，对照组则接受相同的安慰剂胶囊。研究药物对研究人员和受试者都将是双盲的。访问和评估将按以下方式进行：筛选（访问0），1个月（访问1），2个月（访问2）和3个月（访问3）。该研究的主要结果是发现两组之间基线之间的平均收缩压下降和平均舒张压下降之间的统计学差异（通过ABPM（动态血压监测）进行测量）。数据将使用SPSS v16进行分析。讨论据我们所知，这是评估普萘洛尔在抵抗性高血压中作用的首批随机对照试验之一。这项研究将为未来的大规模，多中心临床试验提供必要的基础。结果为阳性或阴性，应该为指导当前和未来有关耐药性高血压治疗的政策提供循证渐进的证据。试验注册斯里兰卡临床试验注册中心，标识符：SLCTR / 2016/002。 2016年1月27日注册;研究协议版本2.1。

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