Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
24/09/2012
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 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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes