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

Stroke Clinical Trial

— HYGIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00741585
• Other study ID #: HYGIA
• Secondary ID: Hygia-2007-440
• Status: Completed
• Phase: Phase 4
• 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
• 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:

Ambulatory blood pressure (BP) measurements (ABPM) correlate more closely with target organ damage and cardiovascular events than clinical cuff measurements. ABPM reveals the significant circadian variation in BP, which in most individuals presents a morning increase, small post-prandial decline, and more extensive lowering during nocturnal rest. However, under certain pathophysiological conditions, the nocturnal BP decline may be reduced (non-dipper pattern) or even reversed (riser pattern). This is clinically relevant since the non-dipper and riser circadian BP patterns constitute a risk factor for left ventricular hypertrophy, albuminuria, cerebrovascular disease, congestive heart failure, vascular dementia, and myocardial infarction. Hence, there is growing interest in how to best tailor and individualize the treatment of hypertension according to the specific circadian BP pattern of each patient.

The reduction of the normal 10-20% sleep-time BP decline that is characteristic of the non-dipper and riser patterns is indeed associated with elevated risk of target organ damage, particularly to the heart (left ventricular hypertrophy, congestive heart failure, and myocardial infarction), brain (stroke), and kidney (albuminuria and progression to end-stage renal failure). These results suggest that cardiovascular risk could be influenced not by BP elevation alone, but also by the magnitude of the circadian BP variability. However, the potential dimension of an altered BP profile is still under debate, as there is current discrepancy on the actual prevalence of a non-dipper BP profile among groups of interest, mainly the elderly, patients with diabetes and patients with resistant hypertension.

Moreover, several independent prospective studies have suggested that nighttime BP may be a better predictor of cardiovascular risk than daytime BP. Common to all previous trials is that prognostic significance of ABPM has relied on a single baseline profile from each participant, without accounting for possible changes in the BP pattern, mainly associated to antihypertensive therapy and aging during follow-up. Moreover, the potential benefit, i.e., reduction in cardiovascular risk, associated with the normalization of the circadian BP variability (e.g., conversion from non-dipper to dipper pattern) from appropriately envisioned treatment strategy is still a matter of debate.

The HYGIA study was designed to investigate, first, the comparative prognostic value of several BP parameters (including, among many others, BP variability, the diurnal/nocturnal ratio, diurnal and nocturnal means, hyperbaric index, slope of morning rise, etc) in the prediction of vascular, metabolic, and renal morbidity and mortality; second, whether potential changes in the circadian BP pattern after treatment with hypertension medications may be associated to changes in the risk of cardiovascular events, stroke, diabetes, and/or chronic kidney disease; and third, in keeping with the second major objective above, to further assess the potential changes in efficacy, safety profile, and/or capability of hypertension medications, used either alone or in combination, to modulate the circadian BP pattern and to reduce vascular, metabolic, and renal risks as a function of the circadian time of administration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21983
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Chronic Kidney Disease
• Essential Hypertension
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic
• Stroke

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

Locations

Country	Name	City	State
Spain	CS Baiona	Baiona	Pontevedra
Spain	CS Bueu	Bueu	Pontevedra
Spain	CS Friol	Friol	Lugo
Spain	CS A Estrada	La Estrada	Pontevedra
Spain	CS A Guarda	La Guardia	Pontevedra
Spain	CS Fingoi	Lugo
Spain	CS Valmiñor	Nigran	Pontevedra
Spain	CS Panxón	Nigrán	Pontevedra
Spain	Complexo Hospitalario Universitario de Ourense	Orense
Spain	CS Lerez	Pontevedra
Spain	CS Tomiño	Tomiño	Pontevedra
Spain	Bioengineering & Chronobilogy Labs., University of Vigo	Vigo	Pontevedra
Spain	CS A Doblada	Vigo	Pontevedra
Spain	CS Calle Cuba	Vigo	Pontevedra
Spain	CS Coia	Vigo	Pontevedra
Spain	CS Sardoma	Vigo	Pontevedra
Spain	CS Teis	Vigo	Pontevedra
Spain	Hospital do Meixoeiro	Vigo	Pontevedra
Spain	CS Vilaboa	Vilaboa	Pontevedra
Spain	CS San Roque	Vilagarcía De Arousa	Pontevedra

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

External Links

•   Official web site for the study