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The Hypertension in the Very Elderly Trial (HYVET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00122811
Recruitment Status : Unknown
Verified August 2007 by Imperial College London.
Recruitment status was:  Active, not recruiting
First Posted : July 22, 2005
Last Update Posted : August 21, 2007
Sponsor:
Collaborators:
British Heart Foundation
Institut de Recherches Internationales Servier
Information provided by:
Imperial College London

Tracking Information
First Submitted Date  ICMJE July 13, 2005
First Posted Date  ICMJE July 22, 2005
Last Update Posted Date August 21, 2007
Study Start Date  ICMJE November 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2007)
All strokes (fatal and non-fatal) [ Time Frame: Duration of trial ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 19, 2005)
All strokes (fatal and non-fatal)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2005)
  • Total mortality
  • Cardiovascular mortality
  • Cardiac mortality
  • Stroke mortality
  • Fracture rates
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Hypertension in the Very Elderly Trial (HYVET)
Official Title  ICMJE The Hypertension in the Very Elderly Trial (HYVET)
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 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Hypertension
Intervention  ICMJE Drug: Indapamide SR 1.5mg; Perindopril 2-4mg
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 2, 2007)
4000
Original Enrollment  ICMJE
 (submitted: July 19, 2005)
2100
Estimated Study Completion Date  ICMJE October 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 80 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   China,   Finland,   Romania,   Russian Federation,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00122811
Other Study ID Numbers  ICMJE RG/97010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Imperial College London
Collaborators  ICMJE
  • British Heart Foundation
  • Institut de Recherches Internationales Servier
Investigators  ICMJE
Principal Investigator: Christopher J Bulpitt, MD, FRCP Imperial College London
PRS Account Imperial College London
Verification Date August 2007

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