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HypertensionPhase 4NCT00122811

The Hypertension in the Very Elderly Trial (HYVET)

A Phase 4 study testing Indapamide SR 1.5mg; Perindopril 2-4mg in people with Hypertension, run by Imperial College London at 7 sites in 6 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 80 years and older
Conditions the study is for
Hypertension
What is being tested?
Indapamide SR 1.5mg; Perindopril 2-4mg
How many people
4,000 participants
Where
7 sitesin 6 countries
Study dates
Nov 2000to Oct 2008
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 80 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

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

Who cannot join

  • 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).
Show all 14Show fewer
  • 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

Trial locations and contacts

7 sites in 6 countries.

7 sites in 6 countries

Bulgaria2 sites

  • Department of Internal Medicine, Clinic of Rheumatology

    Plovdiv, 4002 Plovdiv

  • University Hospital St. Anna

    Sofia, 1784 Sofia

Other trials in Bulgaria

China1 site

  • Dept of Hypertension Fu Wai Hospital

    Beijing, 100037, China

Other trials in China

Finland1 site

  • Kontinkangas Hospital Research

    Oulu, 90015 Oulu

Other trials in Finland

Romania1 site

  • UMF Cluj, Clinica Medicala III

    Cluj-Napoca, 3400, Cluj

Other trials in Romania

Russia1 site

  • State Scientific Research Institute of Internal Medicine, Russian Academy of Medical Sciences Siberian Department

    Novosibirsk

Other trials in Russia

United Kingdom1 site

  • Imperial College London

    London, W12 0NN

Other trials in United Kingdom

About this study

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

Read the 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.

Conditions
Hypertension
Being tested
Indapamide SR 1.5mg; Perindopril 2-4mg
Keywords
Aged, Hypertension, Stroke
Medical subject headings
Hypertension, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Indapamide SR 1.5mg; Perindopril 2-4mgDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All strokes (fatal and non-fatal)

    Measured: Duration of trial

Secondary outcomes (5)

  1. Total mortality

    Measured: duration of trial

  2. Cardiovascular mortality

    Measured: Duration of trial

  3. Cardiac mortality

    Measured: Duration of trial

  4. Stroke mortality

    Measured: Duration of Trial

  5. Fracture rates

    Measured: Duration of trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2005 (estimated)
  2. Study startNov 2000
  3. Study completionOct 2008 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
4,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00122811
Sponsor's protocol ID
RG/97010
Status last verified
Aug 2007
First submitted
13 Jul 2005
Last updated
21 Aug 2007
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 11302283

  • 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.

    PubMed 17177983

  • 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.

    PubMed 16492072

  • 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.

    PubMed 16410734

  • 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.

    PubMed 34028812

  • 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.

    PubMed 27552643

  • 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.

    PubMed 25880068

  • 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.

    PubMed 24920166

  • 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.

    PubMed 23588194

  • 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.

    PubMed 22910302

  • 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.

    PubMed 22218098

  • 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.

    PubMed 20573778

  • 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.

    PubMed 20497949

  • 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.

    PubMed 19250558

  • 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.

    PubMed 18614402

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Indapamide SR 1.5mg; Perindopril 2-4mg in people with Hypertension, run by Imperial College London at 7 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Bulgaria, China, Finland, Romania, Russia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All strokes (fatal and non-fatal) (time frame: Duration of trial). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00122811, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2007.

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