The Hypertension in the Very Elderly Trial (HYVET)

Active, not recruiting

Phase 4 Results

Trial Description

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.

Conditions

Interventions

  • Perindopril (Aceon)Drug
    Intervention Desc: Antihypertensive; angiotensin converting enzyme (ACE) inhibitor
  • Indapamide Drug
    Intervention Desc: A thiazide-like diuretic used, either alone or in combination with other drugs, to treat high blood pressure and to prevent salt and fluid retention associated with heart failure.
  • Indapamide SR 1.5mg; Perindopril 2-4mg Drug

Trial Design

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

Patient Involvement

Treatment consists of indapamide 1.5mg SR (or placebo in the control group) with the addition of perindopril 2mg - 4mg in tablet form once daily to reach a target blood pressure (BP) of <150/80 mmHg.

Outcomes

Type Measure Time Frame Safety Issue
Primary Strokes (fatal and non-fatal).
Secondary Total mortality, cardiovascular mortality, cardiac mortality, stroke mortality, fracture rates.
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

Sponsors