HYpertension in the Very Elderly Trial

ISRCTN	ISRCTN14031168
DOI	https://doi.org/10.1186/ISRCTN14031168
ClinicalTrials.gov number	NCT00122811
Secondary identifying numbers	RG/97010

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Professor CJ Bulpitt
Scientific

Care of the Elderly
Division of Medicine
ICSM at Hammersmith Hospital
Du Cane Road
London
W12 0NN
United Kingdom

Phone	+44 (0)20 8383 3959
Email	c.bulpitt@ic.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	HYVET
Study objectives	To assess the benefits of treating very elderly patients with hypertension.
Ethics approval(s)	Approved by the relevent central and local ethics committees
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Indapamide Sustained Release (SR), perindopril
Primary outcome measure	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 study start date	01/01/2001
Completion date	31/12/2009

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	2100
Key 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
Key exclusion criteria	Does not comply with above inclusion criteria.
Date of first enrolment	01/01/2001
Date of final enrolment	31/12/2009

Care of the Elderly

London
W12 0NN
United Kingdom

British Heart Foundation (UK)
Charity

14 Fitzhardinge Street
London
W1H 6DH
United Kingdom

Charity

British Heart Foundation (UK) (ref: RG/97010)
Private sector organisation / Trusts, charities, foundations (both public and private)

Institut de Recherches Internationales Servier (France)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	main trial protocol	01/07/2001	Yes	No
Protocol article	sub-study protocol	19/12/2006	Yes	No
Results article	results	01/05/2008	Yes	No
Results article	results	01/07/2010	Yes	No