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

Condition	Intervention	Phase
Hypertension	Drug: Indapamide SR 1.5mg; Perindopril 2-4mg	Phase IV

Further Study Details: 

Primary Outcomes: All strokes (fatal and non-fatal)
Secondary Outcomes: Total mortality; Cardiovascular mortality; Cardiac mortality; Stroke mortality; Fracture rates
Expected Total Enrollment:  2100

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.

Ages Eligible for Study:  80 Years and above,  Genders Eligible for Study:  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. 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 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00122811

Nigel S Beckett, MB ChB, MRCP      +44(0)208 383 3959    n.beckett@imperial.ac.uk
Ruth Peters, BSc MSc      +44(0)208 383 3959    r.peters@imperial.ac.uk

Bulgaria
      University Hospital St. Anna, Sofia,  1784 Sofia,  Bulgaria; Recruiting
      Department of Internal Medicine, Clinic of Rheumatology, Plovdiv,  4002 Plovdiv,  Bulgaria; Recruiting
China
      (阜外医院高血压室) Dept of Hypertension Fu Wai Hospital, Beijing,  100037, China,  China; Recruiting
Finland
      Kontinkangas Hospital Research, Oulu,  90015 Oulu,  Finland; Recruiting
Romania
      UMF Cluj, Clinica Medicala III, Cluj,  3400, Cluj,  Romania; Recruiting
Russian Federation
      State Scientific Research Institute of Internal Medicine, Russian Academy of Medical Sciences Siberian Department, Novosibirsk,  Russian Federation; Recruiting
United Kingdom
      Imperial College London, London,  W12 0NN,  United Kingdom; Recruiting

Study chairs or principal investigators

Christopher J Bulpitt, MD, FRCP,  Principal Investigator,  Imperial College London   

Study ID Numbers:  RG/97010
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 21, 2005
ClinicalTrials.gov Identifier:  NCT00122811
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
ClinicalTrials.gov processed this record on 2005-07-26