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Sponsors and Collaborators: |
University of Vigo Servicio Gallego de Salud |
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Information provided by: | University of Vigo |
ClinicalTrials.gov Identifier: | NCT00741585 |
The HYGIA study was designed to investigate prospectively
Condition | Intervention | Phase |
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Essential Hypertension Total Mortality Cardiovascular Disease Stroke Chronic Kidney Disease |
Drug: Any antihypertensive medication alone or in combination Device: Ambulatory blood pressure monitoring |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prognostic Value of the Circadian Pattern of Ambulatory Blood Pressure Monitoring for Cardiovascular Risk Assessment |
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 |
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1: Active Comparator
Treatment with all drugs on awakening
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Drug: Any antihypertensive medication alone or in combination
All drugs on awakening
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
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2: Active Comparator
Treatment with at least one drug at bedtime
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Drug: 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
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ramon C Hermida, PhD | 34986812148 | rhermida@uvigo.es |
Contact: Diana E Ayala, MD, PhD | 34986812148 | dianaelva@hotmail.com |
Spain | |
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 | |
Spain, Lugo | |
CS Friol | Recruiting |
Friol, Lugo, Spain, 27220 | |
Contact: Esther Gomez, MD 34639512093 Esther.Gomez.Sal@sergas.es | |
Principal Investigator: Esther Gomez, MD | |
Spain, Pontevedra | |
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 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 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 Calle Cuba | Recruiting |
Vigo, Pontevedra, Spain, 36202 | |
Contact: Felisa Dominguez, MD 34986416226 fdominguez@meditex.es | |
Principal Investigator: Felisa Dominguez, MD | |
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 | |
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 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 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 | |
CS Valmiñor | Recruiting |
Nigran, Pontevedra, Spain, 36250 | |
Contact: Susana Hernaiz, MD 34655391498 Susana.Hernaiz.Valero@sergas.es | |
Principal Investigator: Susana Hernaiz, 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 | |
Hospital do Meixoeiro | Recruiting |
Vigo, Pontevedra, Spain, 36200 | |
Contact: Roberto Perez, MD 34627517077 roberto.perez.alvarez@sergas.es | |
Principal Investigator: Roberto Perez, MD | |
CS A Doblada | Recruiting |
Vigo, Pontevedra, Spain, 36205 | |
Contact: Teresa Rios, MD 34986275121 teresa.rios.rey@sergas.es | |
Principal Investigator: Teresa Rios, 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 |
Study Director: | Ramon C Hermida, PhD | University of Vigo |
Responsible Party: | University of Vigo ( Ramon C. Hermida ) |
Study ID Numbers: | HYGIA, Hygia-2007-440 |
Study First Received: | August 25, 2008 |
Last Updated: | November 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00741585 |
Health Authority: | Spain: Ministry of Health |
Ambulatory blood pressure monitoring Chronotherapy Circadian |
Non-dipper Type 2 diabetes Resistant hypertension |
Renal Insufficiency Cerebral Infarction Kidney Failure, Chronic Irbesartan Olmesartan medoxomil Ramipril Manidipine Candesartan cilexetil Enalapril Urologic Diseases Kidney Diseases Telmisartan Valsartan Carvedilol Quinapril |
Lercanidipine Stroke Lisinopril Vascular Diseases Diabetes Mellitus Angiotensin II Amlodipine Calcium, Dietary Enalaprilat Renal Insufficiency, Chronic Diabetes Mellitus, Type 2 Candesartan Essential hypertension Atenolol Kidney Failure |
Neurotransmitter Agents Vasodilator Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Cardiotonic Agents Physiological Effects of Drugs Calcium Channel Blockers Enzyme Inhibitors Adrenergic alpha-Antagonists Cardiovascular Agents Antihypertensive Agents |
Protective Agents Pharmacologic Actions Protease Inhibitors Angiotensin II Type 1 Receptor Blockers Membrane Transport Modulators Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Adrenergic beta-Antagonists Adrenergic Antagonists Cardiovascular Diseases |