Overview

The Hypertension in the Very Elderly Trial (HYVET)

Status:
Unknown status
Trial end date:
2008-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Imperial College London
Collaborators:
British Heart Foundation
Institut de Recherches Internationales Servier
Treatments:
Indapamide
Perindopril
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. 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