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The Hypertension in the Very Elderly Trial (HYVET)

Information source: Imperial College London
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Indapamide SR 1.5mg; Perindopril 2-4mg (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Imperial College London

Official(s) and/or principal investigator(s):
Christopher J Bulpitt, MD, FRCP, Principal Investigator, Affiliation: Imperial College London

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.

Clinical Details

Official title: The Hypertension in the Very Elderly Trial (HYVET)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: All strokes (fatal and non-fatal)

Secondary outcome:

Total mortality

Cardiovascular mortality

Cardiac mortality

Stroke mortality

Fracture rates

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.

Eligibility

Minimum age: 80 Years. Maximum age: N/A. Gender(s): Both.

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 ┬Ámol/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

Locations and Contacts

Department of Internal Medicine, Clinic of Rheumatology, Plovdiv 4002 Plovdiv, Bulgaria

University Hospital St. Anna, Sofia 1784 Sofia, Bulgaria

Dept of Hypertension Fu Wai Hospital, Beijing 100037, China, China

Kontinkangas Hospital Research, Oulu 90015 Oulu, Finland

UMF Cluj, Clinica Medicala III, Cluj 3400, Cluj, Romania

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

Imperial College London, London W12 0NN, United Kingdom

Additional Information

Related 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.

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.

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.

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.

Starting date: November 2000
Last updated: August 20, 2007

Page last updated: August 23, 2015

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