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出境医 / 临床实验 / Valsartan Versus Amlodipine Effect on Left Ventricular Multidirectional Deformation and Adipocytokines Level

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

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.


Condition or disease Intervention/treatment Phase
Hypertension Drug: valsartan (160 mg/d) Drug: amlodipine (10 mg/d). Phase 4

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Valsartan Versus Amlodipine Effect on Left Ventricular Multidirectional Deformation and Adipocytokines Level in Hypertensive Patients: Speckle Tracking Echocardiography
Actual Study Start Date : December 1, 2018
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : April 10, 2019
Arms and Interventions
Arm Intervention/treatment
Active Comparator: valsartan
Group I treated with valsartan (160 mg/d, n = 100)
 Drug: valsartan (160 mg/d)
Group I treated with valsartan (160 mg/d, n = 100)
Other Name: Tareg 160 mg
Active Comparator: amlodipine
Group II amlodipine (10 mg/d, n = 100).
 Drug: amlodipine (10 mg/d).
Group II amlodipine (10 mg/d, n = 100).
Other Name: Norvasc 10 mg
No Intervention: Control
30 healthy subjects are enrolled as control group (Group III).
Outcome Measures
Primary Outcome Measures :
  1. 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)


  2. Concentration of Adiponectin (pg/ml) [ Time Frame: three months ]
    Adiponectin is an adipocyte-secreted protein that circulates in the serum

  3. Concentration of Leptin (ng/ml) [ Time Frame: three months ]
    Leptin is a hormone secreted from fat cells that helps to regulate body weight.

  4. 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.

  5. Concentration of hs-CRP (mg/L) [ Time Frame: Three Months ]
    High sensitivity C-reactive protein a biomarker of inflammation and cardiovascular disease risk.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Locations
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Egypt
Tanta University Hospital
Tanta, El-Gharbia, Egypt, 31527
Sponsors and Collaborators
Damanhour University
Tanta University
Investigators
Layout table for investigator information
Study Director: Rehab Werida, Ass. Prof. Damanhour University
Tracking Information
First Submitted Date  ICMJE June 16, 2019
First Posted Date  ICMJE June 19, 2019
Last Update Posted Date June 20, 2019
Actual Study Start Date  ICMJE December 1, 2018
Actual Primary Completion Date April 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 16, 2019)
  • LV mass index [ 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)
  • Adiponectin (pg/ml) [ Time Frame: three months ]
    Adiponectin is an adipocyte-secreted protein that circulates in the serum
  • Leptin (ng/ml) [ Time Frame: three months ]
    Leptin is a hormone secreted from fat cells that helps to regulate body weight.
  • 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.
  • hs-CRP (mg/L) [ Time Frame: Three Months ]
    High sensitivity C-reactive protein a biomarker of inflammation and cardiovascular disease risk.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Valsartan Versus Amlodipine Effect on Left Ventricular Multidirectional Deformation and Adipocytokines Level
Official Title  ICMJE Valsartan Versus Amlodipine Effect on Left Ventricular Multidirectional Deformation and Adipocytokines Level in Hypertensive Patients: Speckle Tracking Echocardiography
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: valsartan (160 mg/d)
    Group I treated with valsartan (160 mg/d, n = 100)
    Other Name: Tareg 160 mg
  • Drug: amlodipine (10 mg/d).
    Group II amlodipine (10 mg/d, n = 100).
    Other Name: Norvasc 10 mg
Study Arms  ICMJE
  • Active Comparator: valsartan
    Group I treated with valsartan (160 mg/d, n = 100)
    Intervention: Drug: valsartan (160 mg/d)
  • Active Comparator: amlodipine
    Group II amlodipine (10 mg/d, n = 100).
    Intervention: Drug: amlodipine (10 mg/d).
  • No Intervention: Control
    30 healthy subjects are enrolled as control group (Group III).
Publications *
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 16, 2019) 		230
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 10, 2019
Actual Primary Completion Date April 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03990480
Other Study ID Numbers  ICMJE Valsartan versus Amlodipine LV
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rehab Werida, Damanhour University
Study Sponsor  ICMJE Damanhour University
Collaborators  ICMJE Tanta University
Investigators  ICMJE
Study Director: Rehab Werida, Ass. Prof. Damanhour University
PRS Account Damanhour University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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