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The Hypertension in the Very Elderly Trial (HYVET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00122811
Recruitment Status : Unknown
Verified August 2007 by Imperial College London.
Recruitment status was:  Active, not recruiting
First Posted : July 22, 2005
Last Update Posted : August 21, 2007
British Heart Foundation
Institut de Recherches Internationales Servier
Information provided by:
Imperial College London

Brief Summary:
The purpose of this study is to assess the benefits and risks of treating very elderly (those aged 80 or older) individuals with hypertension.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Indapamide SR 1.5mg; Perindopril 2-4mg Phase 4

Detailed Description:

The benefit to risk ratio of treating hypertensives aged 80 or older has not been established. It has been suggested that at this age for each stroke prevented there is one non-stroke death. HYVET is designed to help clarify this.

HYVET is a randomised, double-blind, placebo-controlled trial in hypertensive subjects aged 80 or older. Active treatment consists of indapamide 1.5mg SR with the addition of perindopril 2mg - 4mg to reach a target blood pressure (BP) of <150/80 mmHg. Entry criteria include a systolic blood pressure of 160-199 mmHg. Patients with isolated systolic hypertension (ISH) have been recruited since August 2003.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Hypertension in the Very Elderly Trial (HYVET)
Study Start Date : November 2000
Estimated Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. All strokes (fatal and non-fatal) [ Time Frame: Duration of trial ]

Secondary Outcome Measures :
  1. Total mortality [ Time Frame: duration of trial ]
  2. Cardiovascular mortality [ Time Frame: Duration of trial ]
  3. Cardiac mortality [ Time Frame: Duration of trial ]
  4. Stroke mortality [ Time Frame: Duration of Trial ]
  5. Fracture rates [ Time Frame: Duration of trial ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   80 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Aged 80 or older
  • Sitting systolic BP 160-199 mmHg AND sitting diastolic BP < 110 mmHg

Exclusion Criteria:

  • Known accelerated hypertension (retinal haemorrhages or exudates or papilloedema).
  • Overt clinical congestive heart failure requiring treatment with a diuretic or angiotensin converting enzyme inhibitor. Subjects allowed if treated with digoxin only.
  • Renal failure (serum creatinine of more than 150 µmol/l).
  • Previous documented cerebral or subarachnoid haemorrhage in the last 6 months. (Ischaemic cerebral and cardiac events do not exclude, although the patient must be neurologically and cardiologically stable.)
  • Condition expected to severely limit survival, e.g. terminal illness.
  • Known secondary hypertension (e.g. renal artery stenosis, chronic renal insufficiency, and endocrine cause).
  • Gout.
  • Clinical diagnosis of dementia.
  • Resident in a nursing home, i.e. where the dependency and care requirements of the patients are such that they require the regular input of qualified nurses and therefore the majority of staff in the home are nurses (other forms of residential care are acceptable).
  • Unable to stand up or walk
  • Participation in a drug trial within the past month preceding selection.
  • Alcohol or drug abuse.
  • Less than 2 months placebo run-in.
  • Contraindications to use of trial drugs

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 identifier (NCT number): NCT00122811

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Department of Internal Medicine, Clinic of Rheumatology
Plovdiv, Bulgaria, 4002 Plovdiv
University Hospital St. Anna
Sofia, Bulgaria, 1784 Sofia
Dept of Hypertension Fu Wai Hospital
Beijing, China, 100037, China
Kontinkangas Hospital Research
Oulu, Finland, 90015 Oulu
UMF Cluj, Clinica Medicala III
Cluj, Romania, 3400, Cluj
Russian Federation
State Scientific Research Institute of Internal Medicine, Russian Academy of Medical Sciences Siberian Department
Novosibirsk, Russian Federation
United Kingdom
Imperial College London
London, United Kingdom, W12 0NN
Sponsors and Collaborators
Imperial College London
British Heart Foundation
Institut de Recherches Internationales Servier
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Principal Investigator: Christopher J Bulpitt, MD, FRCP Imperial College London
Publications automatically indexed to this study by Identifier (NCT Number):

Layout table for additonal information Identifier: NCT00122811    
Other Study ID Numbers: RG/97010
First Posted: July 22, 2005    Key Record Dates
Last Update Posted: August 21, 2007
Last Verified: August 2007
Keywords provided by Imperial College London:
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators