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

Overview

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

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: April 1, 2019

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.

Interventions

• 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).

Arms, Groups and Cohorts

• Active Comparator: valsartan
  • Group I treated with valsartan (160 mg/d, n = 100)
• Active Comparator: amlodipine
  • Group II amlodipine (10 mg/d, n = 100).
• No Intervention: Control
  • 30 healthy subjects are enrolled as control group (Group III).

Clinical Trial Outcome Measures

Primary Measures

• LV mass index (g/m2)
  • Time Frame: 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)
  • Time Frame: three months
  • Adiponectin is an adipocyte-secreted protein that circulates in the serum
• Concentration of Leptin (ng/ml)
  • Time Frame: three months
  • Leptin is a hormone secreted from fat cells that helps to regulate body weight.
• Concentration of TNF-α (pg/ml)
  • Time Frame: 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)
  • Time Frame: Three Months
  • High sensitivity C-reactive protein a biomarker of inflammation and cardiovascular disease risk.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Damanhour University
• Collaborator
  • Tanta University
• Provider of Information About this Clinical Study
  • Principal Investigator: Rehab Werida, Clinical Pharmacy Lecturer – Damanhour University
• Overall Official(s)
  • Rehab Werida, Ass. Prof., Study Director, Damanhour University

References

Tadic M, Cuspidi C, Ivanovic B, Ilic I, Celic V, Kocijancic V. Influence of White-Coat Hypertension on Left Ventricular Deformation 2- and 3-Dimensional Speckle Tracking Study. Hypertension. 2016 Mar;67(3):592-6. doi: 10.1161/HYPERTENSIONAHA.115.06822. Epub 2016 Jan 4.

Yilmaz MI, Sonmez A, Caglar K, Celik T, Yenicesu M, Eyileten T, Acikel C, Oguz Y, Yavuz I, Vural A. Effect of antihypertensive agents on plasma adiponectin levels in hypertensive patients with metabolic syndrome. Nephrology (Carlton). 2007 Apr;12(2):147-53. doi: 10.1111/j.1440-1797.2007.00764.x.