The Hypertension in the Very Elderly Trial (HYVET)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Imperial College London.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
British Heart Foundation
Institut de Recherches Internationales Servier
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00122811
First received: July 13, 2005
Last updated: August 20, 2007
Last verified: August 2007

July 13, 2005
August 20, 2007
November 2000
Not Provided
All strokes (fatal and non-fatal) [ Time Frame: Duration of trial ]
All strokes (fatal and non-fatal)
Complete list of historical versions of study NCT00122811 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Total mortality
  • Cardiovascular mortality
  • Cardiac mortality
  • Stroke mortality
  • Fracture rates
Not Provided
Not Provided
 
The Hypertension in the Very Elderly Trial (HYVET)
The Hypertension in the Very Elderly Trial (HYVET)

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Hypertension
Drug: Indapamide SR 1.5mg; Perindopril 2-4mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
4000
October 2008
Not Provided

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
Both
80 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   China,   Finland,   Romania,   Russian Federation,   United Kingdom
 
NCT00122811
RG/97010
Yes
Not Provided
Imperial College London
  • British Heart Foundation
  • Institut de Recherches Internationales Servier
Principal Investigator: Christopher J Bulpitt, MD, FRCP Imperial College London
Imperial College London
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP