Contact information
Type
Scientific
Primary contact
Professor SG Ball
ORCID ID
Contact details
Yorkshire Heart Centre
G Floor
Jubilee Wing
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom
+44 0113 243 2799x22185
s.g.ball@leeds.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436117967
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Magnetic resonance imaging (MRI) measurement of left ventricular mass regression.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/08/2002
Overall trial end date
30/11/2009
Reason abandoned
Eligibility
Participant inclusion criteria
All recruited patients will have hypertension and left ventricular hypertrophy.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/08/2002
Recruitment end date
30/11/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Yorkshire Heart Centre
Leeds
LS1 3EX
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Leeds Teaching Hospitals NHS Trust (UK)
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. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22828088
Publication citations
-
Results
Burns J, Ball SG, Worthy G, Struthers AD, Mary DA, Greenwood JP, Hypertensive left ventricular hypertrophy: a mechanistic approach to optimizing regression assessed by cardiovascular magnetic resonance., J. Hypertens., 2012, 30, 10, 2039-2046, doi: 10.1097/HJH.0b013e328356b850.