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

Arterial Hypertension Clinical Trial

— PUZZLE  

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03006796
• Other study ID #: IISR-2015-101477
• Status: Completed
• Start date: January 16, 2017
• Est. completion date: March 31, 2020

Study information

• Verified date: October 2020
• Source: Russian Heart Failure Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: March 31, 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Hypertension
• Hypertension
• Obesity

Locations

Country	Name	City	State
Russian Federation	City Hospital ?5	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Russian Heart Failure Society

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinic systolic blood pressure lowering.	Lowering of clinic systolic blood pressure.	From baseline (Month 0) to the study-end visit (Month 6)
Secondary	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).
Secondary	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).
Secondary	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).