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

Russian Heart Failure Society

Status: Completed

Conditions: Arterial Hypertension

Study type: Observational

Funder types: Other

Identifiers

NCT03006796

IISR-2015-101477

Details and patient eligibility

About

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

Full 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.

Enrollment: 94 patients

Sex: All

Ages: 35 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

94 participants in 2 patient groups

group 1 (AZL/C)

Description:

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)

Description:

Group 2 - patients receiving irbesartan/hydrochlorothiazide 150/12.5 mg or 300/25 mg per once a day for 6 months.