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

NCT03990480 | Completed Phase 4

• 1 other identifier: Valsartan versus Amlodipine LV
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (5)

• LV mass index (g/m2)

  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)

  three months

• Concentration of Adiponectin (pg/ml)

  Adiponectin is an adipocyte-secreted protein that circulates in the serum

  three months

• Concentration of Leptin (ng/ml)

  Leptin is a hormone secreted from fat cells that helps to regulate body weight.

  three months

• Concentration of TNF-α (pg/ml)

  Tumor necrosis factor (TNF or TNF-α) is a major pro-inflammatory cytokine involved in early inflammatory events.

  Three months

• Concentration of hs-CRP (mg/L)

  High sensitivity C-reactive protein a biomarker of inflammation and cardiovascular disease risk.

  Three Months

Study Arms (3)

valsartan

ACTIVE COMPARATOR

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

Drug: valsartan (160 mg/d)

amlodipine

ACTIVE COMPARATOR

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

Drug: amlodipine (10 mg/d).

Control

NO INTERVENTION

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

Interventions

valsartan (160 mg/d) DRUG

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

Also known as: Tareg 160 mg

valsartan

amlodipine (10 mg/d). DRUG

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

Also known as: Norvasc 10 mg

amlodipine

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damanhour University: lead
• Tanta University: collaborator

Study Sites (1)

Tanta University Hospital

Tanta, El-Gharbia, 31527, Egypt

Location

Related Publications (2)

• 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.

  PMID: 26729750 BACKGROUND

• 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.

  PMID: 17371337 BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Valsartan; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Dihydropyridines; Pyridines

Study Officials

• Rehab Werida, Ass. Prof.

  Damanhour University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacy Lecturer

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

Study Record Dates

• First Submitted: June 16, 2019
• First Posted: June 19, 2019
• Study Start: December 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 10, 2019
• Last Updated: June 20, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)