Clinical trial NCT03990480: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Damanhour University
Sponsor class: OTHER
Collaborators: name: Tanta University
First posted: 2019-06-19
Enrollment: 230
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: LV mass index (g/m2)
timeFrame: three months
measure: Concentration of Adiponectin (pg/ml)
timeFrame: three months
measure: Concentration of Leptin (ng/ml)
timeFrame: three months
measure: Concentration of TNF-α (pg/ml)
timeFrame: Three months
measure: Concentration of hs-CRP (mg/L)
timeFrame: Three Months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospital
state: El-Gharbia
Study officials:
affiliation: Damanhour University
name: Rehab Werida, Ass. Prof.
role: STUDY_DIRECTOR
References:
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.
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.