Condition category
Circulatory System
Date applied
18/11/2001
Date assigned
18/11/2001
Last edited
14/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Professor CJ Bulpitt

ORCID ID

Contact details

Care of the Elderly
Division of Medicine
ICSM at Hammersmith Hospital
Du Cane Road
London
W12 0NN
United Kingdom
+44 (0)20 8383 3959
c.bulpitt@ic.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00122811

Protocol/serial number

RG/97010

Study information

Scientific title

Acronym

HYVET

Study hypothesis

To assess the benefits of treating very elderly patients with hypertension.

Ethics approval

Approved by the relevent central and local ethics committees

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Hypertension

Intervention

Two treatment groups:
1. Placebo
2. Indapamide Sustained Release (SR) 1.5 mg plus perindopril 2 - 4 mg if required.

Goal: diastolic blood pressure less than 80 mmHg with systolic pressure less than 150 mmHg.

The patients are followed-up both according to clinical need and every 3 months in the first year and every 6 months thereafter.

Intervention type

Drug

Phase

Not Specified

Drug names

Indapamide Sustained Release (SR), perindopril

Primary outcome measures

Stroke events (fatal and non-fatal).

Secondary outcome measures

1. Total mortality
2. Cardiovascular mortality
3. Cardiac mortality
4. Stroke mortality
5. Skeletal fracture

Overall trial start date

01/01/2001

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. People 80 years old and above
2. Sustained systolic pressure 160 - 199 mmHg and diastolic (phase V) pressure 90 - 109 mmHg
3. No evidence of renal failure or co-morbidity requiring anti-hypertensive treatment

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

2100

Participant exclusion criteria

Does not comply with above inclusion criteria.

Recruitment start date

01/01/2001

Recruitment end date

31/12/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Care of the Elderly
London
W12 0NN
United Kingdom

Sponsor information

Organisation

British Heart Foundation (UK)

Sponsor details

14 Fitzhardinge Street
London
W1H 6DH
United Kingdom
+44 (0)20 7935 0185
research@bhf.org.uk

Sponsor type

Charity

Website

http://www.bhf.org.uk/

Funders

Funder type

Charity

Funder name

British Heart Foundation (UK) (ref: RG/97010)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Funder name

Institut de Recherches Internationales Servier (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2001 main trial protocol in http://www.ncbi.nlm.nih.gov/pubmed/11302283
2. 2006 sub-study protocol in http://www.ncbi.nlm.nih.gov/pubmed/17177983
3. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18378519
4. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20497949

Publication citations

  1. Main trial protocol

    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, 151-164.

  2. Results

    Peters R, Pinto E, Beckett N, Swift C, Potter J, McCormack T, Nunes M, Grimley-Evans J, Fletcher A, Bulpitt C, Association of depression with subsequent mortality, cardiovascular morbidity and incident dementia in people aged 80 and over and suffering from hypertension. Data from the Hypertension in the Very Elderly Trial (HYVET)., Age Ageing, 2010, 39, 4, 439-445, doi: 10.1093/ageing/afq042.

  3. 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, 7, 33, doi: 10.1186/1745-6215-7-33.

  4. Beckett NS, Peters R, Fletcher AE, Staessen JA, Liu L, Dumitrascu D, Stoyanovsky V, Antikainen RL, Nikitin Y, Anderson C, Belhani A, Forette F, Rajkumar C, Thijs L, Banya W, Bulpitt CJ, , Treatment of hypertension in patients 80 years of age or older., N. Engl. J. Med., 2008, 358, 18, 1887-1898, doi: 10.1056/NEJMoa0801369.

Additional files

Editorial Notes