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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00741585
• Date of registration: 25/08/2008
• Prospective Registration: Yes
• Primary sponsor: University of Vigo
• Public title: Prognostic Value of the Circadian Pattern of Ambulatory Blood Pressure for Multiple Risk Assessment HYGIA
• Scientific title: Prognostic Value of the Circadian Pattern of Ambulatory Blood Pressure for Multiple Risk Assessment
• Date of first enrolment: September 1, 2008
• Target sample size: 21983
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00741585
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Spain

Contacts

• Name: Ramon C Hermida, PhD
• Affiliation: University of Vigo

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cardiovascular Disease

Essential Hypertension

Stroke

Chronic Kidney Disease

Intervention(s)

Device: Ambulatory blood pressure monitoring

Drug: Any antihypertensive medication alone or in combination

Primary Outcome(s)

To evaluate the impact of circadian time of treatment in cardiovascular, cerebrovascular, metabolic, and renal risk assessment. [Time Frame: Yearly evaluation for at least ten years]

Secondary Outcome(s)

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. [Time Frame: Yearly evaluation for at least ten years]

To evaluate, for all groups of interest, the prevalence and vascular, metabolic, and renal risk profile of white-coat hypertension. [Time Frame: Yearly evaluation for at least ten years]

To evaluate the influence of circadian time of treatment in BP control of hypertensive patients. [Time Frame: Yearly evaluation for at least ten years]

To evaluate, for all previous objectives, potential differences between men and women. [Time Frame: Yearly evaluation for at least ten years]

To evaluate the influence of age and circadian time of treatment in the prevalence of an altered (non-dipper) BP profile. [Time Frame: Yearly evaluation for at least ten years]

To evaluate the influence of diabetes and circadian time of treatment in the prevalence of an altered (non-dipper) BP profile. [Time Frame: Yearly evaluation for at least ten years]

To evaluate the impact of changes in ambulatory BP in vascular, metabolic, and renal risk assessment. [Time Frame: Yearly evaluation for at least ten years]

To evaluate, for all groups of interest, the prevalence and vascular, metabolic, and renal risk profile of masked hypertension. [Time Frame: Yearly evaluation for at least ten years]

Secondary ID(s)

HYGIA

Hygia-2007-440

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Servicio Gallego de Salud