Arterial Hypertension
Conditions
Keywords
Obesity
Brief summary
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
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.
Interventions
None listed
Sponsors
Russian Heart Failure Society
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. male and female 35-55 year old, 2. diagnosis of I-II grade essential AH, 3. patients with obesity (BMI ≥ 30 kg/m²), 4. patients with untreated AH (office SBP ≥ 140 mmHg, DBP ≥ 90 mmHg, no previous antihypertensive therapy), 5. patients with poorly controlled AH (office SBP ≥ 140 mmHg, DBP ≥ 90 mmHg on previous antihypertensive therapy), 6. written informed consent form (ICF).
Exclusion criteria
1. patients with symptomatic organ damage (myocardial infarction, stroke, angina pectoris, chronic kidney disease stage ≥ 4, diabetes), 2. patients with intolerance of ARB, thiazide diuretics, 3. secondary AH, 4. patients with contraindication to study drugs in accordance with Russian instruction, 5. patients currently enrolled in other clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinic systolic blood pressure lowering. | From baseline (Month 0) to the study-end visit (Month 6) | Lowering of clinic systolic blood pressure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour systolic brachial and central blood pressure lowering. | From baseline (Month 0) to the study-end visit (Month 6). | Lowering of ambulatory brachial and central blood pressure. |
| 24-hour aortic pulse wave velocity reduction. | From baseline (Month 0) to the study-end visit (Month 6). | Lowering of ambulatory aortic pulse wave velocity. |
| 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). | Normalization of abnormal left ventricle geometry assessed by left ventricle mass index and relative wall thickness. |
Countries
Russia
Outcome results
None listed