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Essential Hypertension | Prognostic Value of the Circadian Pattern of Ambulatory Blood Pressure for Multiple Risk Assessment

Essential Hypertension research study

What is the primary objective of this study?

The HYGIA study was designed to investigate prospectively 1. the prognostic value of ambulatory blood pressure (BP) monitoring among subjects primarily evaluated at primary care settings 2. the impact of changes in ambulatory BP during follow-up in cardiovascular, cerebrovascular, metabolic, and renal risk in hypertensive patients 3. the influence of circadian time of treatment in cardiovascular, cerebrovascular, metabolic, and renal risk in hypertensive patients 4. the prevalence of an altered BP profile as a function of antihypertensive treatment, circadian time of treatment, age, and presence of diabetes, among other factors.

Who is eligible to participate?

Inclusion Criteria: - Male or female subjects ≥18 years of age. - High-normal BP or essential hypertension. - Any subject with recommendation for evaluation with ABPM according to the 2007 European Guidelines. - Informed consent to participate in the study prior to any study procedures. Exclusion Criteria: - Known or suspected contraindications to any potential medication under investigation. - Shift-workers. - Inability to communicate and comply with all study requirements. - Persons directly involved in the execution of this protocol. - Intolerants to the use of the ABPM device.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Essential Hypertension

Cardiovascular Disease

Stroke

Chronic Kidney Disease

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Any antihypertensive medication alone or in combinationAll drugs on awakening

Drug:Any antihypertensive medication alone or in combinationOne or more drugs at bedtime

Device:Ambulatory blood pressure monitoringSampling at 20-min intervals from 07:00 to 23:00 and at 30-min intervals at night for 48 consecutive hours

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

1Treatment with all prescribed hypertension medications on awakening

2Treatment with at least one prescribed hypertension medication at bedtime

Study Status

Recruiting

Start Date: September 1, 2008

Completed Date: December 2020

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: To evaluate the impact of circadian time of treatment in cardiovascular, cerebrovascular, metabolic, and renal risk assessment.

Secondary Outcome: To evaluate the influence of circadian time of treatment in BP control of hypertensive patients.

Study sponsors, principal investigator, and references

Principal Investigator: Ramon C Hermida, PhD

Lead Sponsor: University of Vigo

Collaborator: Servicio Gallego de Salud

More information:https://clinicaltrials.gov/show/NCT00741585

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