The Hypertension in the Very Elderly Trial (HYVET) | NCT00122811

Studies
The Hypertension in the Very Elderly Trial (HYVET)

NCT00122811

Sponsor

Imperial College London

Status

Unknown status

Last Update Posted

Aug 21, 2007Estimated

Enrollment

4,000Estimated

Phase

Phase 4

Conditions

Hypertension

Interventions

Indapamide SR 1.5mg; Perindopril 2-4mg

Countries

Bulgaria
China
Finland
Romania
Russia
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2000

Primary Completion Date

Not provided

Completion Date

Oct 2008Estimated

First Submitted Date

Jul 13, 2005

First Submission Date that Met QC Criteria

Jul 19, 2005

First Posted Date

Jul 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2007

Last Update Posted Date

Aug 21, 2007Estimated

Name	Class
British Heart Foundation	OTHER
Institut de Recherches Internationales Servier	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4,000Estimated

Name	Type	Description	Arm Group Labels	Other Names
Indapamide SR 1.5mg; Perindopril 2-4mg	Drug

Measure	Description	Time Frame
All strokes (fatal and non-fatal)		Duration of trial

Measure	Description	Time Frame
Total mortality		duration of trial
Cardiovascular mortality		Duration of trial
Cardiac mortality

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

80 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christopher J Bulpitt, MD, FRCP	Imperial College London	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Internal Medicine, Clinic of Rheumatology		Plovdiv		4002 Plovdiv	Bulgaria
University Hospital St. Anna

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11302283	Background	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. doi: 10.2165/00002512-200118030-00001.
17177983	Background	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. doi: 10.1186/1745-6215-7-33.

ID	Term
D006973	Hypertension
D020521	Stroke

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases

ID	Term
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds