Status:
UNKNOWN
The Hypertension in the Very Elderly Trial (HYVET)
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
British Heart Foundation
Institut de Recherches Internationales Servier
Conditions:
Hypertension
Eligibility:
All Genders
80+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- Aged 80 or older
- Sitting systolic BP 160-199 mmHg AND sitting diastolic BP \< 110 mmHg
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2008
Estimated Enrollment :
4000 Patients enrolled
Trial Details
Trial ID
NCT00122811
Start Date
November 1 2000
End Date
October 1 2008
Last Update
August 21 2007
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Internal Medicine, Clinic of Rheumatology
Plovdiv, Bulgaria, 4002 Plovdiv
2
University Hospital St. Anna
Sofia, Bulgaria, 1784 Sofia
3
Dept of Hypertension Fu Wai Hospital
Beijing, China, 100037, China
4
Kontinkangas Hospital Research
Oulu, Finland, 90015 Oulu