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NCT Number: NCT03006796

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

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

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Key information

Conditions

Arterial Hypertension Body Weight Cardiovascular Diseases Hypertension Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

35 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

City Hospital №5

Moscow, 107015, Russia

About this study

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:

  • Male and female 35-55 year old.
  • Diagnosis of essential arterial hypertension I-II grade.
  • Patients with obesity (BMI ≥ 30 kg/m²)
  • Patients with untreated arterial hypertension (clinic SBP ≥ 140 mmHg, DBP ≥ 90 mmHg and no previous antihypertensive treatment.
  • Patients with poorly controlled arterial hypertension (clinic SBP ≥ 140 mmHg, DBP ≥ 90 mmHg on previous antihypertensive treatment.
  • Written informed consent.

The main exclusion criteria are:

  • Patients with symptomatic organ damage (myocardial infarction, stroke, angina pectoris, chronic kidney disease ≥ 4 grade, diabetes).
  • Patients with secondary arterial hypertension.
  • Patients with intolerance of angiotensin II receptor blockers, thiazide diuretic.
  • Patients with contraindication to study drugs in accordance with Russian instruction.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • male and female 35-55 year old,
  • diagnosis of I-II grade essential AH,
  • patients with obesity (BMI ≥ 30 kg/m²),
  • patients with untreated AH (office SBP ≥ 140 mmHg, DBP ≥ 90 mmHg, no previous antihypertensive therapy),
  • patients with poorly controlled AH (office SBP ≥ 140 mmHg, DBP ≥ 90 mmHg on previous antihypertensive therapy),
  • written informed consent form (ICF).

Exclusion criteria

  • patients with symptomatic organ damage (myocardial infarction, stroke, angina pectoris, chronic kidney disease stage ≥ 4, diabetes),
  • patients with intolerance of ARB, thiazide diuretics,
  • secondary AH,
  • patients with contraindication to study drugs in accordance with Russian instruction,
  • patients currently enrolled in other clinical trials.

Treatment and study plan

Primary outcomes

  1. Clinic systolic blood pressure lowering.

    Time frame: From baseline (Month 0) to the study-end visit (Month 6)

    Lowering of clinic systolic blood pressure.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Russian Heart Failure Society

Other

Registry information

Official study 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).

Acronym: PUZZLE

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 30, 2016
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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