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The Hypertension in the Very Elderly Trial (HYVET)

Primary Purpose

Hypertension

Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Indapamide SR 1.5mg; Perindopril 2-4mg
Sponsored by
Imperial College London
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring Aged, Hypertension, Stroke

Eligibility Criteria

80 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Internal Medicine, Clinic of Rheumatology
  • University Hospital St. Anna
  • Dept of Hypertension Fu Wai Hospital
  • Kontinkangas Hospital Research
  • UMF Cluj, Clinica Medicala III
  • State Scientific Research Institute of Internal Medicine, Russian Academy of Medical Sciences Siberian Department
  • Imperial College London

Outcomes

Primary Outcome Measures

All strokes (fatal and non-fatal)

Secondary Outcome Measures

Total mortality
Cardiovascular mortality
Cardiac mortality
Stroke mortality
Fracture rates

Full Information

First Posted
July 13, 2005
Last Updated
August 20, 2007
Sponsor
Imperial College London
Collaborators
British Heart Foundation, Institut de Recherches Internationales Servier
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1. Study Identification

Unique Protocol Identification Number
NCT00122811
Brief Title
The Hypertension in the Very Elderly Trial (HYVET)
Official Title
The Hypertension in the Very Elderly Trial (HYVET)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Unknown status
Study Start Date
November 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Imperial College London
Collaborators
British Heart Foundation, Institut de Recherches Internationales Servier

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Aged, Hypertension, Stroke

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4000 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Indapamide SR 1.5mg; Perindopril 2-4mg
Primary Outcome Measure Information:
Title
All strokes (fatal and non-fatal)
Time Frame
Duration of trial
Secondary Outcome Measure Information:
Title
Total mortality
Time Frame
duration of trial
Title
Cardiovascular mortality
Time Frame
Duration of trial
Title
Cardiac mortality
Time Frame
Duration of trial
Title
Stroke mortality
Time Frame
Duration of Trial
Title
Fracture rates
Time Frame
Duration of trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher J Bulpitt, MD, FRCP
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Internal Medicine, Clinic of Rheumatology
City
Plovdiv
ZIP/Postal Code
4002 Plovdiv
Country
Bulgaria
Facility Name
University Hospital St. Anna
City
Sofia
ZIP/Postal Code
1784 Sofia
Country
Bulgaria
Facility Name
Dept of Hypertension Fu Wai Hospital
City
Beijing
ZIP/Postal Code
100037, China
Country
China
Facility Name
Kontinkangas Hospital Research
City
Oulu
ZIP/Postal Code
90015 Oulu
Country
Finland
Facility Name
UMF Cluj, Clinica Medicala III
City
Cluj
ZIP/Postal Code
3400, Cluj
Country
Romania
Facility Name
State Scientific Research Institute of Internal Medicine, Russian Academy of Medical Sciences Siberian Department
City
Novosibirsk
Country
Russian Federation
Facility Name
Imperial College London
City
London
ZIP/Postal Code
W12 0NN
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
11302283
Citation
Bulpitt C, Fletcher A, Beckett N, Coope J, Gil-Extremera B, Forette F, Nachev C, Potter J, Sever P, Staessen J, Swift C, Tuomilehto J. Hypertension in the Very Elderly Trial (HYVET): protocol for the main trial. Drugs Aging. 2001;18(3):151-64. doi: 10.2165/00002512-200118030-00001.
Results Reference
background
PubMed Identifier
17177983
Citation
Bulpitt CJ, Peters R, Staessen JA, Thijs L, De Vernejoul MC, Fletcher AE, Beckett NS. Fracture risk and the use of a diuretic (indapamide SR) +/- perindopril: a substudy of the Hypertension in the Very Elderly Trial (HYVET). Trials. 2006 Dec 19;7:33. doi: 10.1186/1745-6215-7-33.
Results Reference
background
PubMed Identifier
16492072
Citation
Peters R, Beckett N, Nunes M, Fletcher A, Forette F, Bulpitt C. A substudy protocol of the hypertension in the Very Elderly Trial assessing cognitive decline and dementia incidence (HYVET-COG) : An ongoing randomised, double-blind, placebo-controlled trial. Drugs Aging. 2006;23(1):83-92. doi: 10.2165/00002512-200623010-00008.
Results Reference
background
PubMed Identifier
16410734
Citation
Pinto E, Bulpitt C, Beckett N, Peters R, Staessen JA, Rajkumar C. Rationale and methodology of monitoring ambulatory blood pressure and arterial compliance in the Hypertension in the Very Elderly Trial. Blood Press Monit. 2006 Feb;11(1):3-8. doi: 10.1097/01.mbp.0000184965.30220.10.
Results Reference
background
PubMed Identifier
34028812
Citation
Cunningham EL, Todd SA, Passmore P, Bullock R, McGuinness B. Pharmacological treatment of hypertension in people without prior cerebrovascular disease for the prevention of cognitive impairment and dementia. Cochrane Database Syst Rev. 2021 May 24;5(5):CD004034. doi: 10.1002/14651858.CD004034.pub4.
Results Reference
derived
PubMed Identifier
27552643
Citation
Antikainen RL, Peters R, Beckett NS, Fagard RH, Wang JG, Rajkumar C, Bulpitt CJ. Left ventricular hypertrophy is a predictor of cardiovascular events in elderly hypertensive patients: Hypertension in the Very Elderly Trial. J Hypertens. 2016 Nov;34(11):2280-6. doi: 10.1097/HJH.0000000000001073.
Results Reference
derived
PubMed Identifier
25880068
Citation
Warwick J, Falaschetti E, Rockwood K, Mitnitski A, Thijs L, Beckett N, Bulpitt C, Peters R. No evidence that frailty modifies the positive impact of antihypertensive treatment in very elderly people: an investigation of the impact of frailty upon treatment effect in the HYpertension in the Very Elderly Trial (HYVET) study, a double-blind, placebo-controlled study of antihypertensives in people with hypertension aged 80 and over. BMC Med. 2015 Apr 9;13:78. doi: 10.1186/s12916-015-0328-1.
Results Reference
derived
PubMed Identifier
24920166
Citation
Peters R, Beckett N, Pereira L, Poulter R, Pinto E, Ma S, Dumitrascu D, Barrowdale D, Butler M, Fletcher A, Bulpitt C. The clock drawing test, mortality, incident cardiovascular events and dementia. Int J Geriatr Psychiatry. 2015 Apr;30(4):416-21. doi: 10.1002/gps.4153. Epub 2014 Jun 12.
Results Reference
derived
PubMed Identifier
23588194
Citation
Antikainen RL, Beckett N, Peters R, Fagard R, Rajkumar C, Wang J, Stoyanovsky V, Barrowdale D, Bulpitt CJ; HYVET Study Group. Prevalence and covariates of electrocardiographic left ventricular hypertrophy in the Hypertension in the Very Elderly Trial. J Hypertens. 2013 Jun;31(6):1224-32. doi: 10.1097/HJH.0b013e32836040a4.
Results Reference
derived
PubMed Identifier
22910302
Citation
Peters R, Beckett N, Poulter R, Burch L, Narkiewicz K, Fagard R, Nitsch D, Wang N, Li M, Fletcher A, Bulpitt C. Kidney function in the very elderly with hypertension: data from the hypertension in the very elderly (HYVET) trial. Age Ageing. 2013 Mar;42(2):253-8. doi: 10.1093/ageing/afs109. Epub 2012 Aug 21.
Results Reference
derived
PubMed Identifier
22218098
Citation
Beckett N, Peters R, Tuomilehto J, Swift C, Sever P, Potter J, McCormack T, Forette F, Gil-Extremera B, Dumitrascu D, Staessen JA, Thijs L, Fletcher A, Bulpitt C; HYVET Study Group. Immediate and late benefits of treating very elderly people with hypertension: results from active treatment extension to Hypertension in the Very Elderly randomised controlled trial. BMJ. 2011 Jan 4;344:d7541. doi: 10.1136/bmj.d7541.
Results Reference
derived
PubMed Identifier
20573778
Citation
Peters R, Beckett N, Burch L, de Vernejoul MC, Liu L, Duggan J, Swift C, Gil-Extremera B, Fletcher A, Bulpitt C. The effect of treatment based on a diuretic (indapamide) +/- ACE inhibitor (perindopril) on fractures in the Hypertension in the Very Elderly Trial (HYVET). Age Ageing. 2010 Sep;39(5):609-16. doi: 10.1093/ageing/afq071. Epub 2010 Jun 23.
Results Reference
derived
PubMed Identifier
20497949
Citation
Peters R, Pinto E, Beckett N, Swift C, Potter J, McCormack T, Nunes M, Grimley-Evans J, Fletcher A, Bulpitt C. Association of depression with subsequent mortality, cardiovascular morbidity and incident dementia in people aged 80 and over and suffering from hypertension. Data from the Hypertension in the Very Elderly Trial (HYVET). Age Ageing. 2010 Jul;39(4):439-45. doi: 10.1093/ageing/afq042. Epub 2010 May 23.
Results Reference
derived
PubMed Identifier
19250558
Citation
Peters R, Beckett N, Forette F, Tuomilehto J, Ritchie C, Walton I, Waldman A, Clarke R, Poulter R, Fletcher A, Bulpitt C. Vascular risk factors and cognitive function among 3763 participants in the Hypertension in the Very Elderly Trial (HYVET): a cross-sectional analysis. Int Psychogeriatr. 2009 Apr;21(2):359-68. doi: 10.1017/S1041610208008302. Epub 2009 Feb 27.
Results Reference
derived
PubMed Identifier
18614402
Citation
Peters R, Beckett N, Forette F, Tuomilehto J, Clarke R, Ritchie C, Waldman A, Walton I, Poulter R, Ma S, Comsa M, Burch L, Fletcher A, Bulpitt C; HYVET investigators. Incident dementia and blood pressure lowering in the Hypertension in the Very Elderly Trial cognitive function assessment (HYVET-COG): a double-blind, placebo controlled trial. Lancet Neurol. 2008 Aug;7(8):683-9. doi: 10.1016/S1474-4422(08)70143-1. Epub 2008 Jul 7.
Results Reference
derived
PubMed Identifier
18378519
Citation
Beckett NS, Peters R, Fletcher AE, Staessen JA, Liu L, Dumitrascu D, Stoyanovsky V, Antikainen RL, Nikitin Y, Anderson C, Belhani A, Forette F, Rajkumar C, Thijs L, Banya W, Bulpitt CJ; HYVET Study Group. Treatment of hypertension in patients 80 years of age or older. N Engl J Med. 2008 May 1;358(18):1887-98. doi: 10.1056/NEJMoa0801369. Epub 2008 Mar 31.
Results Reference
derived

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The Hypertension in the Very Elderly Trial (HYVET)

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