Home versus Office blood pressure MEasurements: Reduction of Unnecessary treatment Study
| ISRCTN | ISRCTN56551999 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56551999 |
- Submission date
- 19/10/2006
- Registration date
- 06/12/2006
- Last edited
- 25/10/2022
- 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 Peter de Leeuw
Scientific
Scientific
P Debyelaan 25
5800
Maastricht
6229 AZ
Netherlands
| Ple@sint.azm.nl |
Study information
| Study design | A multicentre prospective randomised clinical trial with a parallel group design. Patients are followed-up for a period of one year. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | Home versus Office blood pressure MEasurements: Reduction of Unnecessary treatment Study |
| Study acronym | HOMERUS |
| Study objectives | Antihypertensive treatment based on self measured blood pressure values may lead to less use of drugs without leading to worse blood pressure control or more target organ damage as compared to patients who are treated based on conventional office blood pressure measurement. |
| Ethics approval(s) | Informed consent, in accordance with the declaration of Helsinki, has been obtained from all patients prior to entering the study. Good clinical practice is maintained and the study protocol has been approved by the ethical committees of all participating centres before inclusion of patients into the study. |
| Health condition(s) or problem(s) studied | Hypertension |
| Intervention | Group one: patients receive antihypertensive treatment on the basis of self blood pressure measurement. Group two: patients are treated based on conventional office blood pressure measurement. |
| Intervention type | Other |
| Primary outcome measure | 1. Blood pressure value (conventional office blood pressure and 24 hour ambulatory blood pressure) 2. Target organ damage (kidney, heart) 3. Cost and number of antihypertensive drugs |
| Secondary outcome measures | 1. Compliance with treatment 2. Quality of life |
| Overall study start date | 01/10/2001 |
| Completion date | 01/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 430 (216 self-measured pressures, 214 office pressures) |
| Key inclusion criteria | 1. Males and females aged 18 years and above 2. Average blood pressure between 139 and 200 mmHg for systolic or between 90 and 120 mmHg for diastolic blood pressure 3. Participating subjects are physically and mentally able to measure their own blood pressure 4. Subjects are willing to remain in follow-up during a period of one year 5. Signed informed consent |
| Key exclusion criteria | 1. The presence of clinically manifest cardiovascular events (angina pectoris, heart failure, hypertensive encephalopathy, or prior myocardial infarction or cerebrovascular accident) 2. Severe non-cardiovascular disease (e.g. malignancy), which will interfere with adequate follow up 3. Allergy or contra-indications for the antihypertensive drugs used in this study 4. Serum creatinine above 150 micromol/l 5. Clinically significant orthostatic hypotension (a drop in systolic blood pressure of more than 20 mmHg upon standing) 6. Blood pressure devices |
| Date of first enrolment | 01/10/2001 |
| Date of final enrolment | 01/10/2004 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
P Debyelaan 25
Maastricht
6229 AZ
Netherlands
6229 AZ
Netherlands
Sponsor information
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Research organisation
Research organisation
PO Box 93245
Den Haag
2509 AE
Netherlands
| info@zonmw.nl | |
| Website | http://www.zonmw.nl/nl/home/contact.html |
"ROR" |
https://ror.org/01yaj9a77 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) (ref: 945-01-043)
No information available
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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | 01/08/2003 | Yes | No | ||
| Other publications | 01/08/2005 | Yes | No | ||
| Other publications | 01/08/2006 | Yes | No | ||
| Results article | 01/12/2007 | Yes | No | ||
| Results article | 01/12/2007 | Yes | No |
Editorial Notes
25/10/2022: Internal review.
