Condition category
Circulatory System
Date applied
23/02/2006
Date assigned
29/03/2006
Last edited
09/12/2010
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

Prof Allan Struthers

ORCID ID

Contact details

Department of Clinical Pharmacology
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2004CV02

Study information

Scientific title

Acronym

Study hypothesis

Please note that, as of 9th December 2010, the public title of this trial has been changed from "Left ventricular hypertrophy in normotensive individuals: would reducing blood pressure further enhance left ventricular hypertrophy regression? " to "Left ventricular hypertrophy: reduction of blood pressure already in the normal range further regresses left ventricular mass."


There are a significant number of individuals with a normal blood pressure and left ventricular hypertrophy (LVH). Would an extra reduction in blood pressure enhance LVH regression?

Ethics approval

Yes, approved by the Tayside Committee on Medical Research Ethics A
REC on 23/07/2004, reference number: 04/S1401/47

Study design

Randomised, single-blind, placebo-controlled

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Left ventricular hypertrophy

Intervention

Two thirds of patients to receive active medication (normal antihypertensives once daily including: bendroflumethiazide 2.5 mg, amlodipine 5 mg, atenolol 50 mg, doxazosin XL 4 mg, spironolactone 25 mg) to lower blood pressure by 10 mmHg. Remaining third to receive placebo with aim of maintaining blood pressure at levels at start of the trail.

Intervention type

Drug

Phase

Not Specified

Drug names

1. Bendroflumethiazide 2.5 mg once daily
2. Amlodipine 5 mg once daily
3. Atenolol 50 mg once daily
4. Doxazosin XL 4 mg once daily
5. Spironolactone 25 mg once daily

Primary outcome measures

Assess for reduction in left ventricular mass index as calculated from MRI

Secondary outcome measures

Reduction in other markers of cardiovascular risk

Overall trial start date

01/03/2005

Overall trial end date

28/02/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Normal blood pressure
2. Left ventricular hypertrophy
3. On angiotensin converting enzyme (ACE) inhibitor or angiotensin II (AII) receptor blocker or contraindication to both

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

48

Participant exclusion criteria

1. Renal disease
2. Proteinuria
3. Claustrophobia or other contraindication to magnetic resonance imaging (MRI) scanning

Recruitment start date

01/03/2005

Recruitment end date

28/02/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Clinical Pharmacology
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

University of Dundee (UK)

Sponsor details

Research and Innovations Services
11 Perth Road
Dundee
DD1 4HN
United Kingdom

Sponsor type

Not defined

Website

Funders

Funder type

Government

Funder name

Chief Scientist Office

Alternative name(s)

CSO

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

United Kingdom

Alternative name(s)

CSO

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

United Kingdom

Funder name

St Andrews House

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Regent Road

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Edinburgh

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

EH1 3DG

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

CSO grant number: CZB/4/145

Alternative name(s)

CSO

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

United Kingdom

Alternative name(s)

CSO

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

United Kingdom

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. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19858141

Publication citations

  1. Results

    Simpson HJ, Gandy SJ, Houston JG, Rajendra NS, Davies JI, Struthers AD, Left ventricular hypertrophy: reduction of blood pressure already in the normal range further regresses left ventricular mass., Heart, 2010, 96, 2, 148-152, doi: 10.1136/hrt.2009.177238.

Additional files

Editorial Notes