The Hypertension in the Very Elderly Trial (HYVET)
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| ClinicalTrials.gov Identifier: NCT00122811 |
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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
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypertension | Drug: Indapamide SR 1.5mg; Perindopril 2-4mg | Phase 4 |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 4000 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | The Hypertension in the Very Elderly Trial (HYVET) |
| Study Start Date : | November 2000 |
| Estimated Study Completion Date : | October 2008 |
- All strokes (fatal and non-fatal) [ Time Frame: Duration of trial ]
- 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 ]
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| Ages Eligible for Study: | 80 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00122811
| 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 | |
| Principal Investigator: | Christopher J Bulpitt, MD, FRCP | Imperial College London |
Publications:
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 |
| First Posted: | July 22, 2005 Key Record Dates |
| Last Update Posted: | August 21, 2007 |
| Last Verified: | August 2007 |
Keywords provided by Imperial College London:
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Aged Hypertension Stroke |
Additional relevant MeSH terms:
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Hypertension Vascular Diseases Cardiovascular Diseases Perindopril Indapamide Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Diuretics Natriuretic Agents Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Membrane Transport Modulators |