Observational Prospective stUdy of aZilsartan Medoxomil/ Chlorthalidone Compared With Irbesartan/hydrochlorothiaZide Combination Therapy in Patients With arteriaL Hypertension and obEsity in Routine Clinical Practice (PUZZLE).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Clinic systolic blood pressure lowering.
研究概览
简要总结
This is an observational prospective study of azilsartan medoxomil / chlorthalidone compared with irbesartan / hydrochlorothiazide in routine therapy of patients with arterial hypertension and obesity.
详细描述
Observational Prospective stUdy of aZilsartan medoxomil/ chlorthalidone compared with irbesartan/hydrochlorothiaZide combination therapy in patients with arteriaL hypertension and obEsity in routine clinical practice (PUZZLE).
The study population is 94 patients with untreated or poorly controlled arterial hypertension and obesity.
The main inclusion criteria are:
- Male and female 35-55 year old.
- Diagnosis of essential arterial hypertension I-II grade.
- Patients with obesity (BMI ≥ 30 kg/m²)
- Patients with untreated arterial hypertension (clinic SBP ≥ 140 mmHg, DBP ≥ 90 mmHg and no previous antihypertensive treatment.
- Patients with poorly controlled arterial hypertension (clinic SBP ≥ 140 mmHg, DBP ≥ 90 mmHg on previous antihypertensive treatment.
- Written informed consent.
The main exclusion criteria are:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female 35-55 year old,
- •diagnosis of I-II grade essential AH,
- •patients with obesity (BMI ≥ 30 kg/m²),
- •patients with untreated AH (office SBP ≥ 140 mmHg, DBP ≥ 90 mmHg, no previous antihypertensive therapy),
- •patients with poorly controlled AH (office SBP ≥ 140 mmHg, DBP ≥ 90 mmHg on previous antihypertensive therapy),
- •written informed consent form (ICF).
排除标准
- •patients with symptomatic organ damage (myocardial infarction, stroke, angina pectoris, chronic kidney disease stage ≥ 4, diabetes),
- •patients with intolerance of ARB, thiazide diuretics,
- •secondary AH,
- •patients with contraindication to study drugs in accordance with Russian instruction,
- •patients currently enrolled in other clinical trials.
结局指标
主要结局
Clinic systolic blood pressure lowering.
时间窗: From baseline (Month 0) to the study-end visit (Month 6)
Lowering of clinic systolic blood pressure.
次要结局
- 24-hour systolic brachial and central blood pressure lowering.(From baseline (Month 0) to the study-end visit (Month 6).)
- change in proportion of patients with normal and abnormal LV geometry with assessment of LV mass index and relative wall thickness.(From baseline (Month 0) to the study-end visit (Month 6).)
- 24-hour aortic pulse wave velocity reduction.(From baseline (Month 0) to the study-end visit (Month 6).)
研究者
Yury Vasyuk
professor
Russian Heart Failure Society