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
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
-
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.
-
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.
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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.
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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.