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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-04-10

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.

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Thirty control healthy individuals and 200 patients with uncomplicated, essential hypertension were enrolled and followed up for 3 months in a controlled randomized study.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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valsartan

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

Group Type ACTIVE_COMPARATOR

valsartan (160 mg/d)

Intervention Type DRUG

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

amlodipine

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

Group Type ACTIVE_COMPARATOR

amlodipine (10 mg/d).

Intervention Type DRUG

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

Control

30 healthy subjects are enrolled as control group (Group III).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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valsartan (160 mg/d)

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

Intervention Type DRUG

amlodipine (10 mg/d).

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

Intervention Type DRUG

Other Intervention Names

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Tareg 160 mg Norvasc 10 mg

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No