Prognostic Value of the Circadian Pattern of Ambulatory Blood Pressure for Multiple Risk Assessment
HYGIA
2 other identifiers
interventional
21,983
1 country
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2008
Longer than P75 for phase_4
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2008
CompletedFirst Posted
Study publicly available on registry
August 26, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedAugust 28, 2018
August 1, 2018
9.8 years
August 25, 2008
August 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
To evaluate the influence of circadian time of treatment in BP control of hypertensive patients.
Yearly evaluation for at least ten years
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
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
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
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
- +3 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATORTreatment with all prescribed hypertension medications on awakening
2
ACTIVE COMPARATORTreatment with at least one prescribed hypertension medication at bedtime
Interventions
All drugs on awakening
Sampling at 20-min intervals from 07:00 to 23:00 and at 30-min intervals at night for 48 consecutive hours
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Vigolead
- Servicio Gallego de Saludcollaborator
Study Sites (20)
CS Friol
Friol, Lugo, 27220, Spain
CS A Estrada
A Estrada, Pontevedra, 26680, Spain
CS Baiona
Baiona, Pontevedra, 36300, Spain
CS Bueu
Bueu, Pontevedra, 36930, Spain
CS A Guarda
La Guardia, Pontevedra, 36780, Spain
CS Valmiñor
Nigrán, Pontevedra, 36250, Spain
CS Panxón
Nigrán, Pontevedra, 36340, Spain
CS Tomiño
Tomiño, Pontevedra, 36200, Spain
Bioengineering & Chronobilogy Labs., University of Vigo
Vigo, Pontevedra, 36200, Spain
Hospital do Meixoeiro
Vigo, Pontevedra, 36200, Spain
CS Calle Cuba
Vigo, Pontevedra, 36202, Spain
CS A Doblada
Vigo, Pontevedra, 36205, Spain
CS Coia
Vigo, Pontevedra, 36209, Spain
CS Sardoma
Vigo, Pontevedra, 36214, Spain
CS Teis
Vigo, Pontevedra, 36216, Spain
CS Vilaboa
Vilaboa, Pontevedra, 36141, Spain
CS San Roque
Vilagarcía de Arousa, Pontevedra, 36600, Spain
CS Fingoi
Lugo, 27002, Spain
Complexo Hospitalario Universitario de Ourense
Ourense, 32005, Spain
CS Lerez
Pontevedra, 36156, Spain
Related Publications (2)
Hermida RC, Crespo JJ, Dominguez-Sardina M, Otero A, Moya A, Rios MT, Sineiro E, Castineira MC, Callejas PA, Pousa L, Salgado JL, Duran C, Sanchez JJ, Fernandez JR, Mojon A, Ayala DE; Hygia Project Investigators. Bedtime hypertension treatment improves cardiovascular risk reduction: the Hygia Chronotherapy Trial. Eur Heart J. 2020 Dec 21;41(48):4565-4576. doi: 10.1093/eurheartj/ehz754.
PMID: 31641769DERIVEDHermida RC. Sleep-time ambulatory blood pressure as a prognostic marker of vascular and other risks and therapeutic target for prevention by hypertension chronotherapy: Rationale and design of the Hygia Project. Chronobiol Int. 2016;33(7):906-36. doi: 10.1080/07420528.2016.1181078. Epub 2016 May 24.
PMID: 27221952DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ramon C Hermida, PhD
University of Vigo
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 25, 2008
First Posted
August 26, 2008
Study Start
September 1, 2008
Primary Completion
June 30, 2018
Study Completion
June 30, 2018
Last Updated
August 28, 2018
Record last verified: 2018-08