AzTrials
AzTrials

Essential HypertensionPhase 4HYGIANCT00741585

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

A Phase 4 study testing Any antihypertensive medication alone or in combination and Ambulatory blood pressure monitoring in people with Essential Hypertension and Cardiovascular Disease, run by University of Vigo at 20 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Any antihypertensive medication alone or in combination and Ambulatory blood pressure monitoring
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21,983 participants
Where
20 sitesSpain
Study dates
1 Sep 2008to 30 Jun 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Spain20 sites
  • CS A Estrada

    A Estrada, Pontevedra, 26680

  • CS Baiona

    Baiona, Pontevedra, 36300

  • CS Bueu

    Bueu, Pontevedra, 36930

  • CS Friol

    Friol, Lugo, 27220

  • CS A Guarda

    La Guardia, Pontevedra, 36780

  • CS Fingoi

    Lugo, 27002

  • CS Valmiñor

    Nigrán, Pontevedra, 36250

  • CS Panxón

    Nigrán, Pontevedra, 36340

  • Complexo Hospitalario Universitario de Ourense

    Ourense, 32005

  • CS Lerez

    Pontevedra, 36156

  • CS Tomiño

    Tomiño, Pontevedra, 36200

  • Bioengineering & Chronobilogy Labs., University of Vigo

    Vigo, Pontevedra, 36200

  • Hospital do Meixoeiro

    Vigo, Pontevedra, 36200

  • CS Calle Cuba

    Vigo, Pontevedra, 36202

  • CS A Doblada

    Vigo, Pontevedra, 36205

  • CS Coia

    Vigo, Pontevedra, 36209

  • CS Sardoma

    Vigo, Pontevedra, 36214

  • CS Teis

    Vigo, Pontevedra, 36216

  • CS Vilaboa

    Vilaboa, Pontevedra, 36141

  • CS San Roque

    Vilagarcía de Arousa, Pontevedra, 36600

Other trials in Spain

About 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.
Read the detailed 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.

Being tested
Any antihypertensive medication alone or in combination, Ambulatory blood pressure monitoring
Keywords
Ambulatory blood pressure monitoring, Chronotherapy, Circadian, Non-dipper, Type 2 diabetes, Resistant hypertension, Total mortality
Medical subject headings
Essential Hypertension, Cardiovascular Diseases, Stroke, Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Any antihypertensive medication alone or in combinationDrug

    Also called Olmesartan, Irbesartan, Candesartan, Telmisartan

    All drugs on awakening

  • Any antihypertensive medication alone or in combinationDrug

    Also called Olmesartan, Irbesartan, Candesartan, Telmisartan

    One or more drugs at bedtime

  • Ambulatory blood pressure monitoringDevice

    Also called ABPM

    Sampling at 20-min intervals from 07:00 to 23:00 and at 30-min intervals at night for 48 consecutive hours

Study groups in NCT00741585
Study groupRoleWhat they receive
1Active comparatorTreatment with all prescribed hypertension medications on awakening
Receives: Drug: Any antihypertensive medication alone or in combination; Device: Ambulatory blood pressure monitoring
2Active comparatorTreatment with at least one prescribed hypertension medication at bedtime
Receives: Drug: Any antihypertensive medication alone or in combination; Device: Ambulatory blood pressure monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Yearly evaluation for at least ten years

Secondary outcomes (8)
  1. To evaluate the influence of circadian time of treatment in BP control of hypertensive patients.

    Measured: Yearly evaluation for at least ten years

  2. 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.

    Measured: Yearly evaluation for at least ten years

  3. To evaluate the influence of diabetes and circadian time of treatment in the prevalence of an altered (non-dipper) BP profile.

    Measured: Yearly evaluation for at least ten years

  4. To evaluate the influence of age and circadian time of treatment in the prevalence of an altered (non-dipper) BP profile.

    Measured: Yearly evaluation for at least ten years

  5. To evaluate, for all groups of interest, the prevalence and vascular, metabolic, and renal risk profile of white-coat hypertension.

    Measured: Yearly evaluation for at least ten years

  6. To evaluate, for all groups of interest, the prevalence and vascular, metabolic, and renal risk profile of masked hypertension.

    Measured: Yearly evaluation for at least ten years

  7. To evaluate, for all previous objectives, potential differences between men and women.

    Measured: Yearly evaluation for at least ten years

  8. To evaluate the impact of changes in ambulatory BP in vascular, metabolic, and renal risk assessment.

    Measured: Yearly evaluation for at least ten years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2008 (estimated)
  2. Study start1 Sep 2008
  3. Primary completion30 Jun 2018
  4. Study completion30 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
21,983 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00741585
Sponsor's protocol ID
HYGIA
Other IDs
Hygia-2007-440
Acronym
HYGIA
Status last verified
Aug 2018
First submitted
25 Aug 2008
Last updated
28 Aug 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 31641769
  • Hermida 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.

    PubMed 27221952

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Any antihypertensive medication alone or in combination and Ambulatory blood pressure monitoring in people with Essential Hypertension and Cardiovascular Disease, run by University of Vigo at 20 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00741585, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in