The Hypertension in the Very Elderly Trial (HYVET)

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Hypertension in the Very Elderly Trial (HYVET)

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Indapamide SR 1.5mg; Perindopril 2-4mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Indapamide SR 1.5mg; Perindopril 2-4mg|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All strokes (fatal and non-fatal) |  | Duration of trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total mortality |  | duration of trial | 
| Cardiovascular mortality |  | Duration of trial | 
| Cardiac mortality |  | Duration of trial | 
| Stroke mortality |  | Duration of Trial | 
| Fracture rates |  | Duration of trial | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aged, Hypertension, Stroke