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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: valsartan (160 mg/d)
* Drug: amlodipine (10 mg/d).


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Thirty control healthy individuals and 200 patients with uncomplicated, essential hypertension were enrolled and followed up for 3 months in a controlled randomized study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: valsartan<br>Group I treated with valsartan (160 mg/d, n = 100) | Drug: valsartan (160 mg/d)<br>* Group I treated with valsartan (160 mg/d, n = 100)<br>* Other names: Tareg 160 mg;|
| Active Comparator: amlodipine<br>Group II amlodipine (10 mg/d, n = 100). | Drug: amlodipine (10 mg/d).<br>* Group II amlodipine (10 mg/d, n = 100).<br>* Other names: Norvasc 10 mg;|
| No Intervention: Control<br>30 healthy subjects are enrolled as control group (Group III). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LV mass index (g/m2) | 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) | three months | 
| Concentration of Adiponectin (pg/ml) | Adiponectin is an adipocyte-secreted protein that circulates in the serum | three months | 
| Concentration of Leptin (ng/ml) | Leptin is a hormone secreted from fat cells that helps to regulate body weight. | three months | 
| Concentration of TNF-α (pg/ml) | Tumor necrosis factor (TNF or TNF-α) is a major pro-inflammatory cytokine involved in early inflammatory events. | Three months | 
| Concentration of hs-CRP (mg/L) | High sensitivity C-reactive protein a biomarker of inflammation and cardiovascular disease risk. | Three Months |