This is an observational prospective study of azilsartan medoxomil / chlorthalidone compared with irbesartan / hydrochlorothiazide in routine therapy of patients with arterial hypertension and obesity.
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: 1. Male and female 35-55 year old. 2. Diagnosis of essential arterial hypertension I-II grade. 3. Patients with obesity (BMI ≥ 30 kg/m²) 4. Patients with untreated arterial hypertension (clinic SBP ≥ 140 mmHg, DBP ≥ 90 mmHg and no previous antihypertensive treatment. 5. Patients with poorly controlled arterial hypertension (clinic SBP ≥ 140 mmHg, DBP ≥ 90 mmHg on previous antihypertensive treatment. 6. Written informed consent. The main exclusion criteria are: 1. Patients with symptomatic organ damage (myocardial infarction, stroke, angina pectoris, chronic kidney disease ≥ 4 grade, diabetes). 2. Patients with secondary arterial hypertension. 3. Patients with intolerance of angiotensin II receptor blockers, thiazide diuretic. 4. Patients with contraindication to study drugs in accordance with Russian instruction. 5. Patients currently enrolled in other clinical trials. The treatment period is 6 months. The study plan includes 4 basic and 1 additional visits are planned: initial visit, 3 follow-ups (including additional) and study-end visit.
Study Type
OBSERVATIONAL
Enrollment
94
City Hospital №5
Moscow, Russia
Clinic systolic blood pressure lowering.
Lowering of clinic systolic blood pressure.
Time frame: From baseline (Month 0) to the study-end visit (Month 6)
24-hour systolic brachial and central blood pressure lowering.
Lowering of ambulatory brachial and central blood pressure.
Time frame: From baseline (Month 0) to the study-end visit (Month 6).
24-hour aortic pulse wave velocity reduction.
Lowering of ambulatory aortic pulse wave velocity.
Time frame: 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.
Normalization of abnormal left ventricle geometry assessed by left ventricle mass index and relative wall thickness.
Time frame: From baseline (Month 0) to the study-end visit (Month 6).
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