Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
The Hypertension in the Very Elderly Trial (HYVET)
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Imperial College London
British Heart Foundation
Institut De Recherche International Servier
Information provided by: Imperial College London
ClinicalTrials.gov Identifier: NCT00122811
  Purpose

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


Condition Intervention Phase
Hypertension
Drug: Indapamide SR 1.5mg; Perindopril 2-4mg
Phase IV

MedlinePlus related topics: High Blood Pressure
Drug Information available for: Perindopril Perindopril erbumine Indapamide
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: The Hypertension in the Very Elderly Trial (HYVET)

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • All strokes (fatal and non-fatal) [ Time Frame: Duration of trial ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 4000
Study Start Date: November 2000
Estimated Study Completion Date: October 2008
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.

  Eligibility

Ages Eligible for Study:   80 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00122811

Locations
Bulgaria
University Hospital St. Anna
Sofia, Bulgaria, 1784 Sofia
Department of Internal Medicine, Clinic of Rheumatology
Plovdiv, Bulgaria, 4002 Plovdiv
China
Dept of Hypertension Fu Wai Hospital
Beijing, China, 100037, China
Finland
Kontinkangas Hospital Research
Oulu, Finland, 90015 Oulu
Romania
UMF Cluj, Clinica Medicala III
Cluj, Romania, 3400, Cluj
Russian Federation
State Scientific Research Institute of Internal Medicine, Russian Academy of Medical Sciences Siberian Department
Novosibirsk, Russian Federation
United Kingdom
Imperial College London
London, United Kingdom, W12 0NN
Sponsors and Collaborators
Imperial College London
British Heart Foundation
Institut De Recherche International Servier
Investigators
Principal Investigator: Christopher J Bulpitt, MD, FRCP Imperial College London
  More Information

Publications:
Publications indexed to this study:
Study ID Numbers: RG/97010
Study First Received: July 13, 2005
Last Updated: August 20, 2007
ClinicalTrials.gov Identifier: NCT00122811  
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Imperial College London:
Aged
Hypertension
Stroke

Study placed in the following topic categories:
Perindopril
Indapamide
Cerebral Infarction
Stroke
Vascular Diseases
Hypertension

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009