• Total mortality [ Time Frame: duration of trial ]
• Cardiovascular mortality [ Time Frame: Duration of trial ]
• Cardiac mortality [ Time Frame: Duration of trial ]
• Stroke mortality [ Time Frame: Duration of Trial ]
• Fracture rates [ Time Frame: Duration of trial ]

• Total mortality
• Cardiovascular mortality
• Cardiac mortality
• Stroke mortality
• Fracture rates

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

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.

• 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.
• 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. Epub 2009 Feb 27.
• 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. Epub 2008 Jul 7.

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

• British Heart Foundation
• Institut De Recherche International Servier