Clinical trial NCT03006796: Observational Study of Azilsartan/Chlorthalidone and Irbesartan/Hydrochlorothiazide in Hypertension and Obesity.
Official title: 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).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Hypertension
Keywords: Obesity
Lead sponsor: Russian Heart Failure Society
Sponsor class: OTHER
First posted: 2016-12-30
Enrollment: 94
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is 94 patients with untreated or poorly controlled arterial hypertension and obesity 35-55 years old.

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.

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.

Primary outcomes:
measure: Clinic systolic blood pressure lowering.
timeFrame: From baseline (Month 0) to the study-end visit (Month 6)
Secondary outcomes:
measure: 24-hour systolic brachial and central blood pressure lowering.
timeFrame: From baseline (Month 0) to the study-end visit (Month 6).
measure: 24-hour aortic pulse wave velocity reduction.
timeFrame: From baseline (Month 0) to the study-end visit (Month 6).
measure: change in proportion of patients with normal and abnormal LV geometry with assessment of LV mass index and relative wall thickness.
timeFrame: From baseline (Month 0) to the study-end visit (Month 6).
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: City Hospital №5
Study officials:
affiliation: Russian HFS
name: Yury A Vasyuk, MD
role: PRINCIPAL_INVESTIGATOR
References: