Blood Pressure Reduction in Danish General Practice (BRIDGE)

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00244660
First received: October 20, 2005
Last updated: January 17, 2008
Last verified: January 2008
  Purpose

To investigate the effect on blood pressure (BP) control in hypertensive patients using a combination of frequent home - and 24-h ambulatory blood pressure measurement (ABPM) in a Danish general practice (GP) setting.


Condition Intervention Phase
Hypertension
Procedure: Frequent blood pressure measurements
Behavioral: Education
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Blood Pressure Reduction in Danish General Practice (BRIDGE)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change in mean 24-hour (ambulatory) systolic and diastolic blood pressure after 12 months.

Secondary Outcome Measures:
  • Change in clinic and home sysolic and diastolic blood pressure after 12 months, change in systolic and diastolic blood pressure the last 6 hours of the dosing interval (morning blood pressure) and change in over all risk score after 12 months.

Estimated Enrollment: 1000
Study Start Date: November 2005
Estimated Study Completion Date: June 2007
Detailed Description:

Also the beneficial effect of optimal blood pressure (BP) control is well established, sub-optimal blood pressure control is still highly prevalent in the hypertensive population. The purpose of this study is to evaluate the effect of frequent home (HBPM)- and 24 hour (ABPM) blood pressure measurements to achieve BP control in patients with essential hypertension according to Danish Society of Hypertension Gudelines. The study will include 120 general practioners (GP) randomised to perform either usual BP control or intensive BP control. Before randomization, participating GPs will recruit each 10 patients to be followed over a period of 12 months. At baseline ABPM will be measured in all eligible patients. The result of the baseline ABPM will be blinded in the usual care group. Following this, usual care (control) physicians will perform BP control according to their usual standard. Physicians randomized to intensive care will control BP by the use of frequent HBPM and ABPM. According to a pre-specified scheme patients followed by intensive care physicians will measure HBP in the morning and in the evening at three consecutive days after 1, 2, 4, 8 and 10 months in the study. Patients will communicate the results of these measurements to the treating physician, who according to the result of the HBPM will decide what action to take. As a further aid, at 6 month patients in the intensive care group will have another APBM as part of the follow up to ensure 24 hour BP control. In both the usual- and intensive care group all treatment decisions is entirely up to the treating physician. No pre-specified treatment algorithm has to be followed and both non-pharmacological as well as any pharmacological tretment can be used to (optimize) BP control. Patients followed by intensive care will receive extended structured information about the importance of optimal BP control. As the primary endpoint is change in mean 24-hour ambulatory systolic and diastolic blood pressure patients in both groups will have a ABPM after 12 months. During the whole trial, participating physicians will keep a record of all measured BP (clinic BP, HBP and ABP), as well as all relevant blood- and urinary tests (lipids, glucose, albuminuria) taken during the study. Based on all available information, patients total risk score (Danish Society of Hypertension) will be calculated at baseline and after 12 months.

Study Hypothesis:

Blood pressure control according to the Danish Society of Hypertension Guidelines is better obtained by an intensive care regimen (frequent home- and ambulatory blood pressure measurement) compared to a usual care regimen (standard blood pressure control in Danish general practice).

Comparison(s):

Frequent home- and ambulatory blood pressure measurements versus standard care.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria: 18 years or more, informed consent obtained, essential hypertension, able to use a home blood pressure apparatus, can cooperate to ambulatory blood pressure measurement. Exclusion criteria: Pregnancy, hypertension secondary to another disorder.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00244660

Locations
Denmark
Frederiksberg Hospital
Frederiksberg F, Denmark, 2000
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator B.I. Denmark A/S
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00244660     History of Changes
Other Study ID Numbers: 502.504
Study First Received: October 20, 2005
Last Updated: January 17, 2008
Health Authority: Denmark: n/a

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 29, 2014