The Hypertension in the Very Elderly Trial (HYVET)

August 20, 2007 updated by: Imperial College London
The purpose of this study is to assess the benefits and risks of treating very elderly (those aged 80 or older) individuals with hypertension.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

4000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

78 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All strokes (fatal and non-fatal)
Time Frame: Duration of trial
Duration of trial

Secondary Outcome Measures

Outcome Measure
Time Frame
Total mortality
Time Frame: duration of trial
duration of trial
Cardiovascular mortality
Time Frame: Duration of trial
Duration of trial
Cardiac mortality
Time Frame: Duration of trial
Duration of trial
Stroke mortality
Time Frame: Duration of Trial
Duration of Trial
Fracture rates
Time Frame: Duration of trial
Duration of trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

British Heart Foundation
Institut de Recherches Internationales Servier

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2000

Study Completion (Anticipated)

October 1, 2008

Study Registration Dates

First Submitted

July 13, 2005

First Submitted That Met QC Criteria

July 19, 2005

First Posted (Estimate)

July 22, 2005

Study Record Updates

Last Update Posted (Estimate)

August 21, 2007

Last Update Submitted That Met QC Criteria

August 20, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG/97010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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