NCT03990480

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Damanhour University · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Hypertension

Interventions

Type	Name	Description
DRUG	valsartan (160 mg/d)	Group I treated with valsartan (160 mg/d, n = 100)
DRUG	amlodipine (10 mg/d).	Group II amlodipine (10 mg/d, n = 100).

Timeline

• Start date: 2018-12-01
• Primary completion: 2019-04-01
• Completion: 2019-04-10
• First posted: 2019-06-19
• Last updated: 2019-06-20

Locations

1 site across 1 country: Egypt