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

NCT ID: NCT03006796

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 94 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-16
• Study Completion Date: 2020-03-31

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.

Conditions

Arterial Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

group 1 (AZL/C)

Group 1 - patients receiving azilsartan medoxomil/chlorthalidone 40/12.5 mg or 40/25 mg per os once a day for 6 months.

No interventions assigned to this group

group 2 (IRB/H)

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

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Russian Heart Failure Society

OTHER

Sponsor Role: lead

Responsible Party

Yury Vasyuk

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yury A Vasyuk, MD

Role: PRINCIPAL_INVESTIGATOR

Russian HFS

Locations

City Hospital №5

Moscow, , Russia

Countries

Russia

Other Identifiers

IISR-2015-101477

Identifier Type: -

Identifier Source: org_study_id