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Home versus Office blood pressure MEasurements: Reduction of Unnecessary treatment Study
DOI 10.1186/ISRCTN56551999
ClinicalTrials.gov identifier
EudraCT number
Public title Home versus Office blood pressure MEasurements: Reduction of Unnecessary treatment Study
Scientific title
Serial number at source N/A
Study hypothesis 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.
Lay summary
Ethics approval 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.
Study design A multicentre prospective randomised clinical trial with a parallel group design. Patients are followed-up for a period of one year.
Countries of recruitment Netherlands
Disease/condition/study domain Hypertension
Participants - 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
Participants - 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
Anticipated start date 01/10/2001
Anticipated end date 01/10/2004
Status of trial Completed
Patient information material
Target number of participants 430 (216 self-measured pressures, 214 office pressures)
Interventions 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.
Primary outcome measure(s) 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 measure(s) 1. Compliance with treatment
2. Quality of life
Sources of funding The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) (ref: 945-01-043)
Trial website
Publications Results in:
1. http://www.ncbi.nlm.nih.gov/pubmed/17938383
2. http://www.ncbi.nlm.nih.gov/pubmed/16877956
3. http://www.ncbi.nlm.nih.gov/pubmed/16257877
4. http://www.ncbi.nlm.nih.gov/pubmed/14763665
5. http://www.ncbi.nlm.nih.gov/pubmed/18047914
Contact name Prof  Peter  de Leeuw
  Address P Debyelaan 25
  City/town Maastricht
  Zip/Postcode 6229 AZ
  Country Netherlands
  Email Ple@sint.azm.nl
Sponsor The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
  Address PO Box 93245
  City/town Den Haag
  Zip/Postcode 2509 AE
  Country Netherlands
  Email info@zonmw.nl
  Sponsor website: http://www.zonmw.nl/nl/home/contact.html
Date applied 19/10/2006
Last edited 15/04/2008
Date ISRCTN assigned 06/12/2006
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