Therapeutic Adherence in Uncontrolled Arterial Hypertension: Selective Detection by Urine Antihypertensive Drugs or Metabolits Analysis and Effectiveness of a Program to Improve Compliance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Change in 24h-systolic blood pressure.
研究概览
简要总结
In hypertension, highly prevalent, up to 10-15% of hypertensive patients have uncontrolled blood pressure despite being treated with ≥3 drugs, which is known as resistant hypertension. Resistant arterial hypertension, together with difficult-to-control hypertension, has a worse cardiovascular prognosis than controlled hypertension. In addition, data on therapeutic adherence in arterial hypertension show that 1 in 2 hypertensive patients do not fully or partially comply with the indicated therapeutic prescription. The determination of antihypertensive drugs or their metabolites in urine seems to be a good indicator of therapeutic adherence. On the other hand, the implementation of a specific program to improve knowledge of the disease and its risks and promote therapeutic adherence could improve the control of hypertension and reduce the associated morbidity and mortality.
详细描述
Objective
To assess whether the implementation of a specific action plan to improve adherence for 3 months results in reduced peripheral 24h-systolic blood pressure (SBP) in patients with resistant hypertension (RH) or uncontrolled hypertension with 2 antihypertensive drugs.
Method: interventional, prospective, randomized, controlled, parallel groups, open study of a cohort of 150 consecutively recruited patients with RH (office SBP ≥140mmHg and/or diastolic blood pressure ≥90mmHg despite treatment with ≥3 drugs at appropriate doses, one diuretic) or patients with uncontrolled hypertension with 2 antihypertensive drugs, with ambulatory 24h-BP ≥130 and / or 80mmHg. The partially or completely non-adherent patients (confirmed by determination of antihypertensive drugs in urine) will be randomized (1: 1) to receive a specific program to improve adherence (intervention group) or routine follow-up (control group), with office BP measurement and determination of antihypertensive drugs in urine at pre-randomization, 3, 6 and 12 months; peripheral and central 24h-ambulatory BP monitoring will be performed at pre-randomization, at 3 and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Patients are not knowledged whether they are allocated to the control group or to the interventional group
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged ≥18 years
- •diagnosis of resistant hypertension with treatment superior to 3 drugs at maximum dose, one of them being a diuretic
- •uncontrolled hypertension treated with 2 drugs at the maximum effective doses tolerated
- •the prescribed treatment must be stable for the last 2 months
- •given informed consent
排除标准
- •secondary arterial hypertension
- •pregnant women
- •Impossibility to perform a 24-hour blood pressure monitoring, or poor quality results.
- •Recent history of major vascular episode
- •patients receiving treatment with Barnidipino / Felodipine / Lercanidipine / Manidipine / Nifedipine / Verapamil / Eplerenone
结局指标
主要结局
Change in 24h-systolic blood pressure.
时间窗: 3 months
Comparison between groups of change in 24-hour-systolic blood pressure provided by 24h-ambulatory blood pressure monitoring 3 months after randomization
次要结局
- Variation in the degree of therapeutic compliance(3 months)
研究者
Anna Oliveras
Head of Hypertension & Vascular Risk Unit. Nephrology Department
Parc de Salut Mar