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

Primary Purpose

Hypertension

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
valsartan (160 mg/d)
amlodipine (10 mg/d).
Sponsored by
Damanhour University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Tanta University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

valsartan

amlodipine

Control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 16, 2019
Last Updated
June 18, 2019
Sponsor
Damanhour University
Collaborators
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT03990480
Brief Title
Valsartan Versus Amlodipine Effect on Left Ventricular Multidirectional Deformation and Adipocytokines Level
Official Title
Valsartan Versus Amlodipine Effect on Left Ventricular Multidirectional Deformation and Adipocytokines Level in Hypertensive Patients: Speckle Tracking Echocardiography
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
April 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Damanhour University
Collaborators
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Thirty control healthy individuals and 200 patients with uncomplicated, essential hypertension were enrolled and followed up for 3 months in a controlled randomized study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
valsartan
Arm Type
Active Comparator
Arm Description
Group I treated with valsartan (160 mg/d, n = 100)
Arm Title
amlodipine
Arm Type
Active Comparator
Arm Description
Group II amlodipine (10 mg/d, n = 100).
Arm Title
Control
Arm Type
No Intervention
Arm Description
30 healthy subjects are enrolled as control group (Group III).
Intervention Type
Drug
Intervention Name(s)
valsartan (160 mg/d)
Other Intervention Name(s)
Tareg 160 mg
Intervention Description
Group I treated with valsartan (160 mg/d, n = 100)
Intervention Type
Drug
Intervention Name(s)
amlodipine (10 mg/d).
Other Intervention Name(s)
Norvasc 10 mg
Intervention Description
Group II amlodipine (10 mg/d, n = 100).
Primary Outcome Measure Information:
Title
LV mass index (g/m2)
Description
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)
Time Frame
three months
Title
Concentration of Adiponectin (pg/ml)
Description
Adiponectin is an adipocyte-secreted protein that circulates in the serum
Time Frame
three months
Title
Concentration of Leptin (ng/ml)
Description
Leptin is a hormone secreted from fat cells that helps to regulate body weight.
Time Frame
three months
Title
Concentration of TNF-α (pg/ml)
Description
Tumor necrosis factor (TNF or TNF-α) is a major pro-inflammatory cytokine involved in early inflammatory events.
Time Frame
Three months
Title
Concentration of hs-CRP (mg/L)
Description
High sensitivity C-reactive protein a biomarker of inflammation and cardiovascular disease risk.
Time Frame
Three Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rehab Werida, Ass. Prof.
Organizational Affiliation
Damanhour University
Official's Role
Study Director
Facility Information:
Facility Name
Tanta University Hospital
City
Tanta
State/Province
El-Gharbia
ZIP/Postal Code
31527
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26729750
Citation
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.
Results Reference
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PubMed Identifier
17371337
Citation
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.
Results Reference
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Valsartan Versus Amlodipine Effect on Left Ventricular Multidirectional Deformation and Adipocytokines Level

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