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Completed

NCT Number: NCT03990480

Valsartan Versus Amlodipine Effect on Left Ventricular Multidirectional Deformation and Adipocytokines Level

Aim: To evaluate the effects of Valsartan versus Amlodipine on LV deformation in relation to plasma adiponectin and leptin levels in hypertensive individuals.

Methods: LV strain measured by 2 dimensional speckle tracking echocardiography, plasma levels of adiponectin and leptin was determined in 30 healthy individuals served as control group and in 200 hypertensive patients before and after treatment for three months with either Valsartan 160 mg or amlodipine 10 mg.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tanta University Hospital

Tanta, El-Gharbia, 31527, Egypt

About this study

Patients and methods Thirty control healthy individuals and 200 patients with uncomplicated, essential hypertension were enrolled and followed up for 3 months in a controlled randomized study. All subjects' health status was evaluated by a complete medical examination. All BP measurements were made with calibrated mercury manometers (Korotkoff I and V). Three separate measurements were taken at least 2 min apart and the average of these values was calculated. Subjects' height and weight were recorded in the fasting state with the subjects wearing only light clothes and without shoes and BMI was calculated using the equation (BMI = weight (kg)/height (m)2). Patients, of both sexes with mild to moderate essential hypertension (diastolic blood pressure [DBP] >80 and ≤100 mmHg after a 2-week wash-out period, SBP systolic blood pressure>120 and 160 mmHg). Patients were randomly assigned into two groups using a computer-generated random number: Group I treated with valsartan (160 mg/d, n = 100), Group II amlodipine (10 mg/d, n = 100). Another 30 healthy subjects are enrolled as control group (Group III). Subjects in group I and II were asked to maintain their usual dietary and physical activity habits throughout the study. Treatment tolerability was assessed at each follow-up visit.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients, of both sexes with mild to moderate essential hypertension (diastolic blood pressure [DBP] >80 and ≤100 mmHg after a 2-week wash-out period, SBP systolic blood pressure>120 and 160 mmHg). Another 30 healthy subjects are enrolled as control group.

Exclusion criteria

  • Subjects with age < 18 years and >65 years and those with two and more antihypertensive medications, those with diabetes, liver or kidney diseases, angina, myocardial infarction or stroke within 6 months, congestive heart failure, neurologic or psychiatric illness, secondary hypertension, known hypersensitivity to the drugs used in the study. also those with conditions that may have caused metabolic alterations within the past year (pregnancy, abdominal surgery, weight gain or loss of more than 3 kg) are excluded.

Treatment and study plan

valsartan (160 mg/d)

Drug

Group I treated with valsartan (160 mg/d, n = 100)

Other names: Tareg 160 mg

amlodipine (10 mg/d).

Drug

Group II amlodipine (10 mg/d, n = 100).

Other names: Norvasc 10 mg

Primary outcomes

  1. LV mass index (g/m2)

    Time frame: three months

    Left ventricular mass index (LVMI) is a parameter used in echocardiography cardiac MRI.

    LVMI is calculated using the following equations:

    LVMI = LVM (left ventricular mass/body surface area left ventricular mass = 0.8{1.04[([LVEDD + IVSd +PWd]3 - LVEDD3)]} + 0.6 Where

    LVEDD = LV end-diastolic dimension (mm) IVSd = interventricular septal thickness at end-diastole (mm) PWd = posterior wall thickness at end-diastole (mm)

  2. Concentration of Adiponectin (pg/ml)

    Time frame: three months

    Adiponectin is an adipocyte-secreted protein that circulates in the serum

  3. Concentration of Leptin (ng/ml)

    Time frame: three months

    Leptin is a hormone secreted from fat cells that helps to regulate body weight.

  4. Concentration of TNF-α (pg/ml)

    Time frame: Three months

    Tumor necrosis factor (TNF or TNF-α) is a major pro-inflammatory cytokine involved in early inflammatory events.

  5. Concentration of hs-CRP (mg/L)

    Time frame: Three Months

    High sensitivity C-reactive protein a biomarker of inflammation and cardiovascular disease risk.

Sponsors and collaborators

Lead sponsor

Damanhour University

Other

Collaborators

  • Tanta University

Registry information

Official study title

Valsartan Versus Amlodipine Effect on Left Ventricular Multidirectional Deformation and Adipocytokines Level in Hypertensive Patients: Speckle Tracking Echocardiography

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 19, 2019
Registry last updated
Jun 20, 2019

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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