This trial is active, not recruiting.

Condition hypertension
Treatment indapamide sr 1.5mg; perindopril 2-4mg
Phase phase 4
Sponsor Imperial College London
Collaborator British Heart Foundation
Start date November 2000
End date October 2008
Trial size 4000 participants
Trial identifier NCT00122811, RG/97010


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

United States No locations recruiting
Other Countries No locations recruiting

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 Outcomes

All strokes (fatal and non-fatal)
time frame: Duration of trial

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 80 years old.

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

Additional Information

Official title The Hypertension in the Very Elderly Trial (HYVET)
Principal investigator Christopher J Bulpitt, MD, FRCP
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2007.
Information provided to ClinicalTrials.gov by Imperial College London.