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Trial record 96 of 99 for:    AMLODIPINE AND VALSARTAN

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

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ClinicalTrials.gov Identifier: NCT00741585
Recruitment Status : Completed
First Posted : August 26, 2008
Last Update Posted : August 28, 2018
Sponsor:
Collaborator:
Servicio Gallego de Salud
Information provided by (Responsible Party):
Ramon C. Hermida, University of Vigo

Brief 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.

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

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21983 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prognostic Value of the Circadian Pattern of Ambulatory Blood Pressure for Multiple Risk Assessment
Actual Study Start Date : September 1, 2008
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To evaluate the influence of circadian time of treatment in BP control of hypertensive patients. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Yearly evaluation for at least ten years ]
  7. To evaluate, for all previous objectives, potential differences between men and women. [ Time Frame: Yearly evaluation for at least ten years ]
  8. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00741585


Locations
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Spain
CS Friol
Friol, Lugo, Spain, 27220
CS Baiona
Baiona, Pontevedra, Spain, 36300
CS Bueu
Bueu, Pontevedra, Spain, 36930
CS A Estrada
La Estrada, Pontevedra, Spain, 26680
CS A Guarda
La Guardia, Pontevedra, Spain, 36780
CS Valmiñor
Nigran, Pontevedra, Spain, 36250
CS Panxón
Nigrán, Pontevedra, Spain, 36340
CS Tomiño
Tomiño, Pontevedra, Spain, 36200
Bioengineering & Chronobilogy Labs., University of Vigo
Vigo, Pontevedra, Spain, 36200
Hospital do Meixoeiro
Vigo, Pontevedra, Spain, 36200
CS Calle Cuba
Vigo, Pontevedra, Spain, 36202
CS A Doblada
Vigo, Pontevedra, Spain, 36205
CS Coia
Vigo, Pontevedra, Spain, 36209
CS Sardoma
Vigo, Pontevedra, Spain, 36214
CS Teis
Vigo, Pontevedra, Spain, 36216
CS Vilaboa
Vilaboa, Pontevedra, Spain, 36141
CS San Roque
Vilagarcía De Arousa, Pontevedra, Spain, 36600
CS Fingoi
Lugo, Spain, 27002
Complexo Hospitalario Universitario de Ourense
Orense, Spain, 32005
CS Lerez
Pontevedra, Spain, 36156
Sponsors and Collaborators
University of Vigo
Servicio Gallego de Salud
Investigators
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Study Director: Ramon C Hermida, PhD University of Vigo

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ramon C. Hermida, Professor, University of Vigo
ClinicalTrials.gov Identifier: NCT00741585     History of Changes
Other Study ID Numbers: HYGIA
Hygia-2007-440
First Posted: August 26, 2008    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Keywords provided by Ramon C. Hermida, University of Vigo:
Ambulatory blood pressure monitoring
Chronotherapy
Circadian
Non-dipper
Type 2 diabetes
Resistant hypertension
Total mortality
Additional relevant MeSH terms:
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Amlodipine
Valsartan
Kidney Diseases
Renal Insufficiency, Chronic
Hypertension
Essential Hypertension
Cardiovascular Diseases
Vascular Diseases
Urologic Diseases
Renal Insufficiency
Atenolol
Telmisartan
Candesartan
Candesartan cilexetil
Carvedilol
Ramipril
Olmesartan
Olmesartan Medoxomil
Enalapril
Enalaprilat
Lisinopril
Irbesartan
Quinapril
Lercanidipine
Manidipine
Doxazosin
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action