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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00741585
Other study ID # HYGIA
Secondary ID Hygia-2007-440
Status Completed
Phase Phase 4
First received
Last updated
Start date September 1, 2008
Est. completion date June 30, 2018

Study information

Verified date August 2018
Source University of Vigo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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Study Design


Intervention

Drug:
Any antihypertensive medication alone or in combination
All drugs on awakening
Any antihypertensive medication alone or in combination
One or more drugs at bedtime
Device:
Ambulatory blood pressure monitoring
Sampling at 20-min intervals from 07:00 to 23:00 and at 30-min intervals at night for 48 consecutive hours

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Sponsors (2)

Lead Sponsor Collaborator
University of Vigo Servicio Gallego de Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate the impact of circadian time of treatment in cardiovascular, cerebrovascular, metabolic, and renal risk assessment. Yearly evaluation for at least ten years
Secondary To evaluate the influence of circadian time of treatment in BP control of hypertensive patients. Yearly evaluation for at least ten years
Secondary To evaluate the prevalence of an altered (non-dipper) BP profile in patients with resistant hypertension as a function of the circadian time of treatment. Yearly evaluation for at least ten years
Secondary To evaluate the influence of diabetes and circadian time of treatment in the prevalence of an altered (non-dipper) BP profile. Yearly evaluation for at least ten years
Secondary To evaluate the influence of age and circadian time of treatment in the prevalence of an altered (non-dipper) BP profile. Yearly evaluation for at least ten years
Secondary To evaluate, for all groups of interest, the prevalence and vascular, metabolic, and renal risk profile of white-coat hypertension. Yearly evaluation for at least ten years
Secondary To evaluate, for all groups of interest, the prevalence and vascular, metabolic, and renal risk profile of masked hypertension. Yearly evaluation for at least ten years
Secondary To evaluate, for all previous objectives, potential differences between men and women. Yearly evaluation for at least ten years
Secondary To evaluate the impact of changes in ambulatory BP in vascular, metabolic, and renal risk assessment. Yearly evaluation for at least ten years
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