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Prognostic Value of the Circadian Pattern of Ambulatory Blood Pressure for Cardiovascular Risk Assessment (HYGIA)

This study is currently recruiting participants.
Verified December 2012 by University of Vigo
Sponsor:
Collaborator:
Servicio Gallego de Salud
Information provided by (Responsible Party):
Ramon C. Hermida, University of Vigo
ClinicalTrials.gov Identifier:
NCT00741585
First received: August 25, 2008
Last updated: December 20, 2012
Last verified: December 2012
History of Changes
  Purpose

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 and renal risk in hypertensive patients
  3. the influence of circadian time of treatment in cardiovascular, cerebrovascular 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.

Condition Intervention Phase
Essential Hypertension
Cardiovascular Disease
Stroke
Chronic Kidney Disease
 Drug: Any antihypertensive medication alone or in combination
Device: Ambulatory blood pressure monitoring
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prognostic Value of the Circadian Pattern of Ambulatory Blood Pressure for Cardiovascular Risk Assessment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Vigo:

Primary Outcome Measures:
  • To evaluate the impact of circadian time of treatment in cardiovascular, cerebrovascular and renal risk assessment. [ Time Frame: Yearly evaluation for at least ten years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the influence of circadian time of treatment in BP control of hypertensive patients. [ Time Frame: Yearly evaluation for at least ten years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • To evaluate, for all groups of interest, the prevalence and cardiovascular risk profile of white-coat hypertension. [ Time Frame: Yearly evaluation for at least ten years ] [ Designated as safety issue: Yes ]
  • To evaluate, for all groups of interest, the prevalence and cardiovascular risk profile of masked hypertension. [ Time Frame: Yearly evaluation for at least ten years ] [ Designated as safety issue: Yes ]
  • To evaluate, for all previous objectives, potential differences between men and women. [ Time Frame: Yearly evaluation for at least ten years ] [ Designated as safety issue: Yes ]
  • To evaluate the impact of changes in ambulatory BP in cardiovascular, cerebrovascular and renal risk assessment. [ Time Frame: Yearly evaluation for at least ten years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5000
Study Start Date: January 2008
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Treatment with all prescribed hypertension medications on awakening
 Drug: Any antihypertensive medication alone or in combination
All drugs on awakening
Other Names:
  • Olmesartan
  • Irbesartan
  • Candesartan
  • Telmisartan
  • Valsartan
  • Atenolol
  • Carvedilol
  • Nevibolol
  • Doxazosine
  • Lercanidipine
  • Manidipine
  • Amlodipine
  • Ramipril
  • Enalapril
  • Lisinopril
  • Quinapril
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
Other Name: ABPM
Active Comparator: 2
Treatment with at least one prescribed hypertension medication at bedtime
 Drug: Any antihypertensive medication alone or in combination
One or more drugs at bedtime
Other Names:
  • Olmesartan
  • Irbesartan
  • Candesartan
  • Telmisartan
  • Valsartan
  • Atenolol
  • Carvedilol
  • Nevibolol
  • Doxazosine
  • Lercanidipine
  • Manidipine
  • Amlodipine
  • Ramipril
  • Enalapril
  • Lisinopril
  • Quinapril
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
Other Name: ABPM

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, microalbuminuria, 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 (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 cardiovascular morbidity and mortality; second, whether potential changes in the circadian BP pattern after treatment with antihypertensive medications may be associated to changes in the risk of cardiovascular events, stroke, 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 antihypertensive medication, used either alone or in combination, to modulate the circadian BP pattern as a function of the circadian time of administration.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741585

Contacts
Contact: Ramon C Hermida, PhD 34986812148 rhermida@uvigo.es
Contact: Diana E Ayala, MD, PhD 34986812148 dianaelva@hotmail.com

Locations
Spain
CS Friol Recruiting
Friol, Lugo, Spain, 27220
Contact: Esther Gomez, MD     34639512093     Esther.Gomez.Sal@sergas.es    
Principal Investigator: Esther Gomez, MD            
CS Bayona Recruiting
Bayona, Pontevedra, Spain, 36300
Contact: Francisco J Iglesias, MD     34986357239     FranciscoJavier.Iglesias.Mato@sergas.es    
Principal Investigator: Francisco J Iglesias, MD            
CS Bueu Recruiting
Bueu, Pontevedra, Spain, 36930
Contact: Miguel A Aboal, MD     34986323313     miguel.angel.aboal.beato@sergas.es    
Principal Investigator: Miguel A Aboal, MD            
CS A Estrada Recruiting
La Estrada, Pontevedra, Spain, 26680
Contact: Luis Meijide, MD     34986573459     Luis.Meijide.Calvo@sergas.es    
Principal Investigator: Luis Meijide, MD            
Sub-Investigator: Mariana Carbon, MD            
Sub-Investigator: Maria C Garcia, MD            
Sub-Investigator: Francisco Romero, MD            
Sub-Investigator: Maria P Brea            
CS A Guarda Recruiting
La Guardia, Pontevedra, Spain, 36780
Contact: Juan J Crespo, MD     34986614450     JuanJose.Crespo.Sabaris@sergas.es    
Principal Investigator: Juan J Crespo, MD            
Sub-Investigator: Raquel Fernandez, MD            
Sub-Investigator: Carmen M Fernandez, MD            
Sub-Investigator: Amelia Ferreras, MD            
Sub-Investigator: Manuel Quintans, MD            
Sub-Investigator: Javier Rodriguez, MD            
Sub-Investigator: Pilar Rua, MD            
Sub-Investigator: Aurelio Alvarez            
Sub-Investigator: Asuncion Cadilla            
Sub-Investigator: Carmen Outeiro            
Sub-Investigator: Carmen Soto-Davila            
CS Valmiñor Recruiting
Nigran, Pontevedra, Spain, 36250
Contact: Susana Hernaiz, MD     34655391498     Susana.Hernaiz.Valero@sergas.es    
Principal Investigator: Susana Hernaiz, MD            
CS Panxón Recruiting
Nigrán, Pontevedra, Spain, 36340
Contact: Jose L Salgado, MD     34986368615     joseluis.salgado.conde@sergas.es    
Principal Investigator: Jose L Salgado, MD            
Sub-Investigator: Esperanza Parrado            
Sub-Investigator: Alfredo Pereira            
CS Tomiño Recruiting
Tomiño, Pontevedra, Spain, 36200
Contact: Evangelina Filloy, MD     34-986-623411     evangelina.filloy.miguez@sergas.es    
Principal Investigator: Evangelina Filloy, MD            
Sub-Investigator: Adolfo T Perez, MD            
Sub-Investigator: Nieves Turienzo, MD            
Sub-Investigator: Dolores Cardalda            
Sub-Investigator: Jose C Varela            
Sub-Investigator: Francisca Vazquez            
Bioengineering & Chronobilogy Labs., University of Vigo Recruiting
Vigo, Pontevedra, Spain, 36200
Contact: Ramon C Hermida, PhD     34986812148     rhermida@uvigo.es    
Contact: Diana E Ayala, MD, PhD     34986812148     dianaelva@uvigo.es    
Principal Investigator: Ramon C Hermida, PhD            
Principal Investigator: Diana E Ayala, MD, PhD            
Sub-Investigator: Artemio Mojon, PhD            
Sub-Investigator: Jose R Fernandez, PhD            
Sub-Investigator: Ignacio Alonso, PhD            
Sub-Investigator: Maria J Fontao            
Sub-Investigator: Rita Soler            
Sub-Investigator: Susana Serrano            
CS A Doblada Recruiting
Vigo, Pontevedra, Spain, 36205
Contact: Teresa Rios, MD     34986275121     teresa.rios.rey@sergas.es    
Principal Investigator: Teresa Rios, MD            
CS Calle Cuba Recruiting
Vigo, Pontevedra, Spain, 36202
Contact: Felisa Dominguez, MD     34986416226     fdominguez@meditex.es    
Principal Investigator: Felisa Dominguez, MD            
CS Coia Recruiting
Vigo, Pontevedra, Spain, 36209
Contact: Peregrina Eiroa, MD     34986209282     pereeiroa@telefonica.net    
Principal Investigator: Peregrina Eiroa, MD, PhD            
Sub-Investigator: Jesus C Nieto, MD            
CS Sardoma Recruiting
Vigo, Pontevedra, Spain, 36214
Contact: Manuel Dominguez, MD, PhD     34986416324     Manuel.Dominguez.Sardina@sergas.es    
Principal Investigator: Manuel Dominguez, MD, PhD            
CS Teis Recruiting
Vigo, Pontevedra, Spain, 36216
Contact: Pedro A Callejas, MD     34986374229     PedroAntonio.Callejas.Cabanillas@sergas.es    
Principal Investigator: Pedro A Callejas, MD            
Hospital do Meixoeiro Recruiting
Vigo, Pontevedra, Spain, 36200
Contact: Roberto Perez, MD     34627517077     roberto.perez.alvarez@sergas.es    
Principal Investigator: Roberto Perez, MD            
CS Vilaboa Recruiting
Vilaboa, Pontevedra, Spain, 36141
Contact: Sonia M Gomara, MD     34986679229     SoniaMaria.Gomara.Villabona@sergas.es    
Principal Investigator: Sonia M Gomara, MD            
Sub-Investigator: Julio J Alvarez, MD            
Sub-Investigator: Margarita Estevez            
Sub-Investigator: Maria C Ferreira            
CS San Roque Recruiting
Villagarcia de Arosa, Pontevedra, Spain, 36600
Contact: Envira Sineiro, MD     34986507448     Elvira.Sineiro.Galinanes@sergas.es    
Principal Investigator: Elvira Sineiro, MD            
Sub-Investigator: Margarita Alvariño            
Sub-Investigator: Luis M Fontenla            
Sub-Investigator: Margarita Fraga, MD            
Sub-Investigator: Barbara Llovo            
Sub-Investigator: Rita Martinez            
Sub-Investigator: Santiago Santidrian, MD            
CS Fingoi Recruiting
Lugo, Spain, 27002
Contact: Carmen Castiñeira, MD     34982251035     Carmen.Castineira.Perez@sergas.es    
Principal Investigator: Carmen Castiñeira, MD            
Sub-Investigator: Maria C Aguado            
Sub-Investigator: Carmen Costa            
Sub-Investigator: Domingo D Garcia, MD            
Sub-Investigator: Bernardino Pardo, MD            
Sub-Investigator: Enrique J Vazquez, MD            
Complexo Hospitalario Universitario de Ourense Recruiting
Orense, Spain, 32005
Contact: Alfonso Otero, MD, PhD     34988385625     Alfonso.Santiago.Otero.Gonzalez@sergas.es    
Principal Investigator: Alfonso Otero, MD, PhD            
CS Lerez Recruiting
Pontevedra, Spain, 36156
Contact: Ana Moya, MD     34986871496     ana.moya.alvarez@sergas.es    
Principal Investigator: Ana Moya, MD            
Sub-Investigator: Andres Ruiz, MD            
Sub-Investigator: Aurelia Constenla            
Sub-Investigator: Maria I Franco            
Sponsors and Collaborators
University of Vigo
Servicio Gallego de Salud
Investigators
Study Director: Ramon C Hermida, PhD University of Vigo
  More Information

Additional Information:
Official web site for the study  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Ramon C. Hermida, Professor, University of Vigo
ClinicalTrials.gov Identifier: NCT00741585     History of Changes
Other Study ID Numbers: HYGIA, Hygia-2007-440
Study First Received: August 25, 2008
Last Updated: December 20, 2012
Health Authority: Spain: Ministry of Health

Keywords provided by University of Vigo:
Ambulatory blood pressure monitoring
Chronotherapy
Circadian
Non-dipper
 Type 2 diabetes
Resistant hypertension
Total mortality

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertension
Kidney Diseases
Stroke
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Vascular Diseases
Urologic Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Renal Insufficiency
Carvedilol
Manidipine
 Quinapril
Candesartan
Candesartan cilexetil
Valsartan
Irbesartan
Lercanidipine
Antihypertensive Agents
Atenolol
Enalapril
Amlodipine
Lisinopril
Ramipril
Telmisartan
Olmesartan
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013