The Hypertension in the Very Elderly Trial (HYVET)

Hypertension Clinical Trial

Official title:

The Hypertension in the Very Elderly Trial (HYVET)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00122811
• Other study ID #: RG/97010
• Status: Active, not recruiting
• Phase: Phase 4
• First received: July 13, 2005
• Last updated: August 20, 2007
• Start date: November 2000
• Est. completion date: October 2008

Study information

• Verified date: August 2007
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4000
• Est. completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 80 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Indapamide SR 1.5mg; Perindopril 2-4mg

Locations

Country	Name	City	State
Bulgaria	Department of Internal Medicine, Clinic of Rheumatology	Plovdiv
Bulgaria	University Hospital St. Anna	Sofia
China	Dept of Hypertension Fu Wai Hospital	Beijing
Finland	Kontinkangas Hospital Research	Oulu
Romania	UMF Cluj, Clinica Medicala III	Cluj
Russian Federation	State Scientific Research Institute of Internal Medicine, Russian Academy of Medical Sciences Siberian Department	Novosibirsk
United Kingdom	Imperial College London	London

Sponsors (3)

Lead Sponsor	Collaborator
Imperial College London	British Heart Foundation, Institut de Recherches Internationales Servier

Countries where clinical trial is conducted

Bulgaria,  China,  Finland,  Romania,  Russian Federation,  United Kingdom, 

References & Publications (4)

Bulpitt C, Fletcher A, Beckett N, Coope J, Gil-Extremera B, Forette F, Nachev C, Potter J, Sever P, Staessen J, Swift C, Tuomilehto J. Hypertension in the Very Elderly Trial (HYVET): protocol for the main trial. Drugs Aging. 2001;18(3):151-64. — View Citation

Bulpitt CJ, Peters R, Staessen JA, Thijs L, De Vernejoul MC, Fletcher AE, Beckett NS. Fracture risk and the use of a diuretic (indapamide SR) +/- perindopril: a substudy of the Hypertension in the Very Elderly Trial (HYVET). Trials. 2006 Dec 19;7:33. — View Citation

Peters R, Beckett N, Nunes M, Fletcher A, Forette F, Bulpitt C. A substudy protocol of the hypertension in the Very Elderly Trial assessing cognitive decline and dementia incidence (HYVET-COG) : An ongoing randomised, double-blind, placebo-controlled trial. Drugs Aging. 2006;23(1):83-92. — View Citation

Pinto E, Bulpitt C, Beckett N, Peters R, Staessen JA, Rajkumar C. Rationale and methodology of monitoring ambulatory blood pressure and arterial compliance in the Hypertension in the Very Elderly Trial. Blood Press Monit. 2006 Feb;11(1):3-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All strokes (fatal and non-fatal)		Duration of trial
Secondary	Total mortality		duration of trial
Secondary	Cardiovascular mortality		Duration of trial
Secondary	Cardiac mortality		Duration of trial
Secondary	Stroke mortality		Duration of Trial
Secondary	Fracture rates		Duration of trial