Observational Study of Azilsartan/Chlorthalidone and Irbesartan/Hydrochlorothiazide in Hypertension and Obesity.

Study Overview
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Brief Summary
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This is an observational prospective study of azilsartan medoxomil / chlorthalidone compared with irbesartan / hydrochlorothiazide in routine therapy of patients with arterial hypertension and obesity.

Detailed Description
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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: Patients with symptomatic organ damage (myocardial infarction, stroke, angina pectoris, chronic kidney disease ≥ 4 grade, diabetes). Patients with secondary arterial hypertension. Patients with intolerance of angiotensin II receptor blockers, thiazide diuretic. Patients with contraindication to study drugs in accordance with Russian instruction. 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.

Official Title
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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).

Conditions
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Arterial Hypertension

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| group 1 (AZL/C)<br>Group 1 - patients receiving azilsartan medoxomil/chlorthalidone 40/12.5 mg or 40/25 mg per os once a day for 6 months. | |
| group 2 (IRB/H)<br>Group 2 - patients receiving irbesartan/hydrochlorothiazide 150/12.5 mg or 300/25 mg per once a day for 6 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinic systolic blood pressure lowering. | Lowering of clinic systolic blood pressure. | From baseline (Month 0) to the study-end visit (Month 6) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour systolic brachial and central blood pressure lowering. | Lowering of ambulatory brachial and central blood pressure. | 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. | 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. | From baseline (Month 0) to the study-end visit (Month 6). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity