Ignite Creation Date:
2024-05-06 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03626259
Status:
UNKNOWN
Last Update Posted:
2018-08-17
First Post:
2018-08-08
Brief Title:
LosartanAmlodipine on Hemodynamics Parameters and Arterial Stiffness in Arterial Hypertension
Sponsor:
Centro Universitario de Ciencias de la Salud Mexico
Organization:
Centro Universitario de Ciencias de la Salud Mexico
Study Overview
Official Title:
Effect of the Administration of Losartan Amlodipine in Fixed Combination Versus Losartan on Hemodynamic and Arterial Stiffness Parameters in Patients With Systemic Hypertension Grade 1 and 2
Status:
UNKNOWN
Status Verified Date:
2018-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Systemic Arterial Hypertension SAH is a disease with a high prevalence in Mexico and worldwide SAH is associated with an increase in cardiovascular morbidity and mortality causing cardiovascular disease CVD heart failure HF as well as chronic kidney disease CKD Several of the physiopathological mechanisms observed are the increase in cardiac output central aortic pressure CAP pulse wave velocity PWV and peripheral vascular resistance PVR which leads to the generation of damage to the target organ The identification not only of the peripheral arterial pressure but also of these hemodynamic parameters and arterial stiffness would allow a better cardiovascular characterization of the patients However the measurements of hemodynamic parameters and arterial stiffness can vary during the 24 hours from individual to individual by all known mechanisms involved in the regulation of blood pressure such as cortisol central nervous system the peripheral nervous system along with the renin angiotensin and aldosterone system which are usually only measured in a single moment Generally the choice of drug in a patient with SAH is based only on the values of peripheral blood pressure at the time of the measurement The use of oscillometric equipment such as the Mobil-O-Graph 24 allows to the investigators to know the hemodynamic and arterial stiffness behavior during 24 hours therefore this could favor the choice of the most appropriate antihypertensive drug dose and administration time The use of angiotensin II receptor antagonists ARA II At1 blockers such as losartan and calcium channel blockers CCB for instance amlodipine have shown a reduction in CAP and peripheral blood pressure respectively in patients with SAH The most prescribed drugs in health units worldwide are enalapril amlodipine losartan and atenolol of which the most used combination is losartan with amlodipine There are no studies to date that allow investigators to identify the effect of the administration of losartan amlodipine in a fixed combination form on the hemodynamic parameters and arterial stiffness of patients with SAH Therefore the objective of the present study is to evaluate the effect of this fixed combination versus losartan on hemodynamic and arterial stiffness parameters based on the behavior of these for 24 hours
Detailed Description:
In the present investigation the investigators expect to know the effect of the administration of losartan amlodipine in fixed combination versus losartan on hemodynamic parameters and arterial stiffness in patients with arterial hypertension grade 1 and 2 For this purpose the investigators will conduct a double-blind randomized trial each group will be compose by 14 male and female patients 40-65 years old with hypertension neither with diabetes nor being under triple pharmacological therapy Randomization will determine who will receive the intervention during an 8- week trial losartanamlodipine in fixed combination capsule 100mg5mg 1 time daily or losartan capsule 100mg 1 time daily The clinical findings and laboratory tests include a metabolic profile and biosafety which will be at baseline and by the 8th week Body weight body fat body mass index BMI and blood pressure will be determined during the initial and final visit in addition to hemodynamics parameters of arterial stiffness like cardiac output central aortic pressure CAP pulse wave velocity PWV and peripheral vascular resistance PVR by an oscillometric monitoring system via Mobil-O -Graph 24 Adverse events and adherence to treatment will be documented Statistical analysis Mann-Whitney U Test and Wilcoxon exact test It is considered with significance at p005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None