The Hypertension in the Very Elderly Trial (HYVET)

Phase 4

• Conditions: Hypertension

• Registration Number: NCT00122811
• Lead Sponsor: Imperial College London

Brief 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.

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.

Study Timeline

• Study Start: 2000-11
• Study First Submitted: 2005-07-13
• Study First Submitted QC: 2005-07-19
• Study First Posted: 2005-07-22
• Status Verified: 2007-08
• Last Update Submitted: 2007-08-20
• Last Update Posted: 2007-08-21
• Study Completion: 2008-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
All strokes (fatal and non-fatal)	Duration of trial

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

UMF Cluj, Clinica Medicala III; 🇷🇴 Cluj, Romania

Department of Internal Medicine, Clinic of Rheumatology; 🇧🇬 Plovdiv, Bulgaria

Kontinkangas Hospital Research; 🇫🇮 Oulu, Finland

University Hospital St. Anna; 🇧🇬 Sofia, Bulgaria

Dept of Hypertension Fu Wai Hospital; 🇨🇳 Beijing, China

Imperial College London; 🇬🇧 London, United Kingdom

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