Ambulatory Blood Pressure Monitoring for Antihypertensive Treatment Guidance

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00139984
First received: August 29, 2005
Last updated: August 29, 2007
Last verified: July 2007
  Purpose

The purpose of this study is to determine whether in patients with arterial hypertension, treatment guidance using 24-hour blood pressure measurement results in better blood pressure control compared to treatment guidance using office blood pressure measurement.


Condition Intervention Phase
Hypertension
Device: 24 hour blood pressure measurement
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Impact of Ambulatory Blood Pressure Monitoring for Antihypertensive Treatment Guidance in Medical Outpatients: The Hyper-ABC Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Change in 24-hour systolic blood pressure from baseline to 1 year

Secondary Outcome Measures:
  • Change in 24-hour diastolic blood pressure from baseline to 1 year
  • Primary outcome measure in patients with treated hypertension at baseline

Estimated Enrollment: 170
Study Start Date: October 2003
Study Completion Date: May 2007
Detailed Description:

Blood pressure control in arterial hypertension remains poor, despite the availability of effective drug treatment. Therefore, strategies to increase blood pressure control are urgently needed. 24 hour blood pressure is a better predictor of cardiovascular morbidity and mortality than office blood pressure. Furthermore, the lower variability of measurements over time of 24 hour blood pressure could allow better adjustment of antihypertensive therapy. However, there are only scarce data about antihypertensive treatment adjustment using 24 hour blood pressure instead of office blood pressure.

Aim: To test the hypothesis that a 24 hour blood pressure guided therapy is is more effective in reaching blood pressure control when compared to conventional office blood pressure guided therapy.

  Eligibility

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

Inclusion Criteria:

  • Uncontrolled hypertension (office BP >139/89mmHg AND 24h BP >129/79mmHg)

Exclusion Criteria:

  • Severe concomitant illness including heart failure, significant valvular heart disease or malignancy
  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: NCT00139984

Locations
Switzerland
Medical Outpatient Clinic, University Hospital Basel
Basel, Switzerland, 4031
Private Practice
Basel, Switzerland, 4057
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Bayer
Investigators
Principal Investigator: David Conen, MD Cardiology, University Hospital Basel
Principal Investigator: Benedict Martina, MD Medical Outpatient Clinic, University Hospital Basel
  More Information

No publications provided by University Hospital, Basel, Switzerland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00139984     History of Changes
Other Study ID Numbers: EKBB183/03
Study First Received: August 29, 2005
Last Updated: August 29, 2007
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
Hypertension
Ambulatory blood pressure monitoring
Blood pressure
Risk assessment

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014