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.
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
- Conditions the study is for
- Essential Hypertension, Cardiovascular Disease, Stroke
- 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
About this study
The HYGIA study was designed to investigate prospectively
- the prognostic value of ambulatory blood pressure (BP) monitoring among subjects primarily evaluated at primary care settings
- the impact of changes in ambulatory BP during follow-up in cardiovascular, cerebrovascular, metabolic, and renal risk in hypertensive patients
- the influence of circadian time of treatment in cardiovascular, cerebrovascular, metabolic, and renal risk in hypertensive patients
- 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 group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Treatment with all prescribed hypertension medications on awakening Receives: Drug: Any antihypertensive medication alone or in combination; Device: Ambulatory blood pressure monitoring |
| 2 | Active comparator | Treatment 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.
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)
To evaluate the influence of circadian time of treatment in BP control of hypertensive patients.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Yearly evaluation for at least ten years
To evaluate, for all previous objectives, potential differences between men and women.
Measured: Yearly evaluation for at least ten years
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.
- First posted26 Aug 2008 (estimated)
- Study start1 Sep 2008
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Vigo
- Sponsor type
- University, hospital or other
- Collaborators
- Servicio Gallego de Salud
- Responsible party
- Principal investigator, Ramon C. Hermida, University of Vigo
- Investigators
- Ramon C Hermida, PhD, Study director, University of Vigo
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 31641769Hermida 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of the Circadian Pattern of Ambulatory Blood Pressure for Multiple Risk Assessment
- ClinicalTrials.gov ID
- NCT00741585
- Acronym / sponsor ID
- HYGIA / HYGIA
- Keywords
- Ambulatory blood pressure monitoring, Chronotherapy, Circadian, Non-dipper, Type 2 diabetes, Resistant hypertension, Total mortality
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21,983 participants (actual)
- Lead sponsor
- University of VigoUniversity, hospital or other
- Collaborators
- Servicio Gallego de Salud
- Study start
- 1 Sep 2008 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 26 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The HYGIA study was designed to investigate prospectively
- the prognostic value of ambulatory blood pressure (BP) monitoring among subjects primarily evaluated at primary care settings
- the impact of changes in ambulatory BP during follow-up in cardiovascular, cerebrovascular, metabolic, and renal risk in hypertensive patients
- the influence of circadian time of treatment in cardiovascular, cerebrovascular, metabolic, and renal risk in hypertensive patients
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Any antihypertensive medication alone or in combination, Device: Ambulatory blood pressure monitoringTreatment with all prescribed hypertension medications on awakening |
| 2 | Active comparator | Drug: Any antihypertensive medication alone or in combination, Device: Ambulatory blood pressure monitoringTreatment with at least one prescribed hypertension medication at bedtime |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Any antihypertensive medication alone or in combinationAlso: Olmesartan, Irbesartan, Candesartan, TelmisartanAll drugs on awakening | Drug | 1 |
| Any antihypertensive medication alone or in combinationAlso: Olmesartan, Irbesartan, Candesartan, TelmisartanOne or more drugs at bedtime | Drug | 2 |
| Ambulatory blood pressure monitoringAlso: ABPMSampling at 20-min intervals from 07:00 to 23:00 and at 30-min intervals at night for 48 consecutive hours | Device | 1, 2 |
Primary outcome
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
8 secondary outcomes
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 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 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 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, 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, 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
To evaluate, for all previous objectives, potential differences between men and women.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Derived from this study: PubMed 31641769Hermida 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.
- Derived from this study: PubMed 27221952Hermida 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.
- Official web site for the studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramon C Hermida, PhD study director
University of Vigo
20 sites in 1 country: see every site and its status.
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.