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

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: valsartan (160 mg/d); Drug: amlodipine (10 mg/d).

• Registration Number: NCT03990480
• Lead Sponsor: Damanhour University

Brief 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.

Study Timeline

• Study Start: 2018-12-01
• Primary Completion: 2019-04-01
• Study Completion: 2019-04-10
• Status Verified: 2019-06
• Study First Submitted: 2019-06-16
• Study First Submitted QC: 2019-06-16
• Last Update Submitted: 2019-06-18
• Study First Posted: 2019-06-19
• Last Update Posted: 2019-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Tanta University Hospital; 🇪🇬 Tanta, El-Gharbia, Egypt