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 |
| Protocol serial number | 2004CV02 |
| Sponsor | University of Dundee (UK) |
| Funders | Chief Scientist Office, St Andrews House, Regent Road, Edinburgh, EH1 3DG, CSO grant number: CZB/4/145 |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, single-blind, placebo-controlled |
| Secondary study design | Randomised controlled trial |
| 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 |
| 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(s) |
Assess for reduction in left ventricular mass index as calculated from MRI |
| Key secondary outcome measure(s) |
Reduction in other markers of cardiovascular risk |
| Completion date | 28/02/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- Scotland
Study participating centre
Department of Clinical Pharmacology
Dundee
DD1 9SY
United Kingdom
DD1 9SY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
