Losartan/Amlodipine on Hemodynamics Parameters and Arterial Stiffness in Arterial Hypertension

NCT03626259 | Unknown Phase 4 DMC

• 1 other identifier: CUCS-INTEC-MV-LOAM-001
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

hypertension; losartan/amlodipine; arterial stiffness

Outcome Measures

Primary Outcomes (1)

• Pulse Wave Velocity (PWVao)

  Before and after intervention with oscillometric monitoring system via Mobil-O -Graph® 24. Maximum score 12 m/s

  56 days

Secondary Outcomes (7)

• Peripheral vascular resistance

  56 days

• Cardiac output

  56 days

• Pulse Pressure (PP)

  56 days

• Augmentation Index (AIx)

  56 days

• Systolic blood pressure

  56 days

Study Arms (2)

losartan and amlodipine

OTHER

Individuals with SAH grade 1 or 2 without triple pharmacological therapy.

Drug: Losartan and Amlodipine

Losartan

ACTIVE COMPARATOR

Individuals with SAH grade 1 or 2 without triple pharmacological therapy.

Drug: Losartan

Interventions

Losartan and Amlodipine DRUG

Losartan and amlodipine in fixed combination capsules, 100mg/5mg. One time daily with the first bite of eat meal per 8 weeks

Also known as: Bicartial

losartan and amlodipine

Losartan DRUG

Losartan capsules, 100mg. One time daily with the first bite of eat meal per 8 weeks

Losartan

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of hypertension grade 1 or 2 according to the criteria of the American Heart Association (2017)
• Written informed consent
• Patients who are undergoing antihypertensive treatment and who, at the trial of the investigator and taking care of the health and safety of the patient, can undergo at least 2 weeks of washing prior to the visit of day 0 (it will be evaluated on a case-by-case basis).

You may not qualify if:

• Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥120 mmHg
• Diabetes Mellitus
• Treated with triple pharmacological therapy
• Untreated thyroid disease
• Total cholesterol \>400mg/dl
• Triglycerides \>400mg/dl
• Liver enzymes (alt and ast) more tan twice the normal range
• Glomerular filtration rate \<60ml/min (Cockcroft-Gault)

Sponsors & Collaborators

• Centro Universitario de Ciencias de la Salud, Mexico: lead

Study Sites (1)

Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Guadalajara, Jalisco, 44340, Mexico

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

amlodipine-losartan drug combination; Losartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Fernando Grover Paez, PhD

  Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando Grover Paez, PhD

CONTACT

3310585200; fgroverp@hotmail.com

Fernando Grover Paez, PhD

CONTACT

3310585200; fgroverpaez@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind (subject, investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: assignment

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 10, 2018
• Study Start: August 6, 2018
• Primary Completion: January 15, 2019
• Study Completion: June 14, 2019
• Last Updated: August 17, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)