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

October 14, 2020 updated by: Yury Vasyuk, Russian Heart Failure Society

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).

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

94

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinic systolic blood pressure lowering.
Time Frame: From baseline (Month 0) to the study-end visit (Month 6)
Lowering of clinic systolic blood pressure.
From baseline (Month 0) to the study-end visit (Month 6)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-hour systolic brachial and central blood pressure lowering.
Time Frame: From baseline (Month 0) to the study-end visit (Month 6).
Lowering of ambulatory brachial and central blood pressure.
From baseline (Month 0) to the study-end visit (Month 6).
24-hour aortic pulse wave velocity reduction.
Time Frame: From baseline (Month 0) to the study-end visit (Month 6).
Lowering of ambulatory aortic pulse wave velocity.
From baseline (Month 0) to the study-end visit (Month 6).
change in proportion of patients with normal and abnormal LV geometry with assessment of LV mass index and relative wall thickness.
Time Frame: 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.
From baseline (Month 0) to the study-end visit (Month 6).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Russian Heart Failure Society

Investigators

  • Principal Investigator: Yury A Vasyuk, MD, Russian HFS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 16, 2017

Primary Completion (ACTUAL)

February 1, 2020

Study Completion (ACTUAL)

March 31, 2020

Study Registration Dates

First Submitted

December 27, 2016

First Submitted That Met QC Criteria

December 27, 2016

First Posted (ESTIMATE)

December 30, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 14, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IISR-2015-101477

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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