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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Hypertension in the Very Elderly Trial (HYVET)

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122811

Locations
Bulgaria
Department of Internal Medicine, Clinic of Rheumatology
Plovdiv, Bulgaria, 4002 Plovdiv
University Hospital St. Anna
Sofia, Bulgaria, 1784 Sofia
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 Recherches Internationales Servier
Investigators
Principal Investigator: Christopher J Bulpitt, MD, FRCP Imperial College London
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00122811     History of Changes
Other Study ID Numbers: RG/97010
Study First Received: July 13, 2005
Last Updated: August 20, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Imperial College London:
Aged
Hypertension
Stroke

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014