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Trial record 3 of 100 for:    AMLODIPINE AND VALSARTAN

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

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ClinicalTrials.gov Identifier: NCT03990480
Recruitment Status : Completed
First Posted : June 19, 2019
Last Update Posted : June 20, 2019
Sponsor:
Collaborator:
Tanta University
Information provided by (Responsible Party):
Rehab Werida, 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.


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.

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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

Resource links provided by the National Library of Medicine


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).



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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03990480


Locations
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Egypt
Tanta University Hospital
Tanta, El-Gharbia, Egypt, 31527
Sponsors and Collaborators
Damanhour University
Tanta University
Investigators
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Study Director: Rehab Werida, Ass. Prof. Damanhour University

Publications:
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Responsible Party: Rehab Werida, Clinical Pharmacy Lecturer, Damanhour University
ClinicalTrials.gov Identifier: NCT03990480     History of Changes
Other Study ID Numbers: Valsartan versus Amlodipine LV
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Amlodipine
Valsartan
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists