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

Damanhour University

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: valsartan (160 mg/d); Drug: amlodipine (10 mg/d).

Study type: Interventional

Funder types: Other

Identifiers

NCT03990480

Valsartan versus Amlodipine LV

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 230 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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230 participants in 3 patient groups

valsartan

Active Comparator group

Description:

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

Treatment:

Drug: valsartan (160 mg/d)

amlodipine

Active Comparator group

Description:

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

Treatment:

Drug: amlodipine (10 mg/d).

Control

No Intervention group

Description:

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