Pathophysiological mechanisms of hypertensive left ventricular hypertrophy: optimising regression

ISRCTN	ISRCTN79725810
DOI	https://doi.org/10.1186/ISRCTN79725810
Secondary identifying numbers	N0436117967

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 24/09/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Professor SG Ball
Scientific

Yorkshire Heart Centre
G Floor
Jubilee Wing
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom

Phone	+44 0113 243 2799x22185
Email	s.g.ball@leeds.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	We aim to investigate the mechanisms responsible for the development of hypertensive left ventricular hypertrophy (LVH), and determine the optimal treatment strategy. We aim to investigate the mechanisms responsible for the development of hypertensive left ventricular hypertrophy (LVH), and determine the optimal treatment strategy. LVH is thought to be related to activation of the renin-angiotensin system and the sympathetic nervous system, in addition to the effect of the high blood pressure. We will accurately determine baseline LV mass using cardiac MRI as well as measuring the degree of humoral and neural activation. Patients will be randomised to different combinations of standard blood pressure treatments for 4 months and then reassessed. We hope to determine whether controlling blood pressure by specifically targeting the neurohumoral activation is more effective in regressing LVH than simple blood pressure control alone. It is hoped that this study will yield useful information regarding the best treatment for hypertensive LVH.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cardiovascular: Hypertensive left ventricular hypertrophy (LVH)
Intervention	Laboratory study; Randomised controlled trial, Random allocation to different combinations of standard blood pressure treatments. Random allocation to: A. Treatment one B. Treatment two C. Treatment three D. Treatment four
Intervention type	Other
Primary outcome measure	Magnetic resonance imaging (MRI) measurement of left ventricular mass regression.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/08/2002
Completion date	30/11/2009

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key inclusion criteria	All recruited patients will have hypertension and left ventricular hypertrophy.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/08/2002
Date of final enrolment	30/11/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Yorkshire Heart Centre

Leeds
LS1 3EX
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Government

Leeds Teaching Hospitals NHS Trust (UK)

No information available

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2012		Yes	No