Left ventricular hypertrophy: reduction of blood pressure already in the normal range further regresses left ventricular mass
| ISRCTN | ISRCTN48331653 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48331653 |
| Secondary identifying numbers | 2004CV02 |
- Submission date
- 23/02/2006
- Registration date
- 29/03/2006
- Last edited
- 09/12/2010
- 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
Prof Allan Struthers
Scientific
Scientific
Department of Clinical Pharmacology
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
Study information
| Study design | Randomised, single-blind, placebo-controlled |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | 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(s) | Yes, approved by the Tayside Committee on Medical Research Ethics A REC on 23/07/2004, reference number: 04/S1401/47 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 measure | Assess for reduction in left ventricular mass index as calculated from MRI |
| Secondary outcome measures | Reduction in other markers of cardiovascular risk |
| Overall study start date | 01/03/2005 |
| Completion date | 28/02/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 48 |
| Key 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 |
| Key exclusion criteria | 1. Renal disease 2. Proteinuria 3. Claustrophobia or other contraindication to magnetic resonance imaging (MRI) scanning |
| Date of first enrolment | 01/03/2005 |
| Date of final enrolment | 28/02/2007 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Department of Clinical Pharmacology
Dundee
DD1 9SY
United Kingdom
DD1 9SY
United Kingdom
Sponsor information
University of Dundee (UK)
Not defined
Not defined
Research and Innovations Services
11 Perth Road
Dundee
DD1 4HN
United Kingdom
"ROR" |
https://ror.org/03h2bxq36 |
|---|
Funders
Funder type
Government
Chief Scientist Office
Government organisation / Local government
Government organisation / Local government
- Alternative name(s)
- CSO
- Location
- United Kingdom
St Andrews House
No information available
Regent Road
No information available
Edinburgh
No information available
EH1 3DG
No information available
CSO grant number: CZB/4/145
Government organisation / Local government
Government organisation / Local government
- Alternative name(s)
- CSO
- Location
- United Kingdom
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 | 01/01/2010 | Yes | No |
