Condition category
Circulatory System
Date applied
19/10/2006
Date assigned
06/12/2006
Last edited
15/04/2008
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 Peter de Leeuw

ORCID ID

Contact details

P Debyelaan 25
5800
Maastricht
6229 AZ
Netherlands
Ple@sint.azm.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

HOMERUS

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.

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.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/10/2001

Overall trial end date

01/10/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

430 (216 self-measured pressures, 214 office pressures)

Participant 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

Recruitment start date

01/10/2001

Recruitment end date

01/10/2004

Locations

Countries of recruitment

Netherlands

Trial participating centre

P Debyelaan 25
Maastricht
6229 AZ
Netherlands

Sponsor information

Organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Sponsor details

PO Box 93245
Den Haag
2509 AE
Netherlands
info@zonmw.nl

Sponsor type

Research organisation

Website

http://www.zonmw.nl/nl/home/contact.html

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) (ref: 945-01-043)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

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

Publication citations

  1. Verberk WJ, Kroon AA, Lenders JW, Kessels AG, van Montfrans GA, Smit AJ, van der Kuy PH, Nelemans PJ, Rennenberg RJ, Grobbee DE, Beltman FW, Joore MA, Brunenberg DE, Dirksen C, Thien T, de Leeuw PW, , Self-measurement of blood pressure at home reduces the need for antihypertensive drugs: a randomized, controlled trial., Hypertension, 2007, 50, 6, 1019-1025, doi: 10.1161/HYPERTENSIONAHA.107.094193.

  2. Verberk WJ, Kroon AA, Kessels AG, Lenders JW, Thien T, van Montfrans GA, Smit AJ, de Leeuw PW, The optimal scheme of self blood pressure measurement as determined from ambulatory blood pressure recordings., J. Hypertens., 2006, 24, 8, 1541-1548, doi: 10.1097/01.hjh.0000239289.87141.b6.

  3. Verberk WJ, Kroon AA, Kessels AG, Nelemans PJ, Van Ree JW, Lenders JW, Thien T, Bakx JC, Van Montfrans GA, Smit AJ, Beltman FW, De Leeuw PW, Comparison of randomization techniques for clinical trials with data from the HOMERUS-trial., Blood Press., 2005, 14, 5, 306-314, doi: 10.1080/08037050500331538.

  4. Verberk WJ, Kroon AA, Kessels AG, Dirksen C, Nelemans PJ, Lenders JW, Thien TA, van Montfrans GA, Smit AJ, de Leeuw PW, Home versus Office blood pressure MEasurements: Reduction of Unnecessary treatment Study: rationale and study design of the HOMERUS trial., Blood Press., 2003, 12, 5-6, 326-333.

  5. Verberk WJ, Thien T, Kroon AA, Lenders JW, van Montfrans GA, Smit AJ, de Leeuw PW, Prevalence and persistence of masked hypertension in treated hypertensive patients., Am. J. Hypertens., 2007, 20, 12, 1258-1265, doi: 10.1016/j.amjhyper.2007.08.002.

Additional files

Editorial Notes