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The Effects of Blood Pressure Reduction on Cerebral Perfusion and Cognition in the Elderly Population (MBRACE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by Radboud University.
Recruitment status was:  Not yet recruiting
Dutch Heart Foundation
Information provided by:
Radboud University Identifier:
First received: August 17, 2009
Last updated: August 25, 2009
Last verified: August 2009
The purpose of this study is to determine if a reduction in systolic blood pressure induced by anti-hypertensive medication results in changes in cerebral perfusion and cognition in hypertensive elderly. Hypertensive elderly will be treated using open-label anti-hypertensive medication for 8-12 weeks. Changes in cerebral perfusion and cognition will be assessed before and after treatment.

Condition Intervention Phase
Hypertension Drug: anti-hypertensive medication Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Medication Induced Blood Pressure Reduction; Assessment of Cerebral Perfusion and Cognition in Hypertensive Elderly

Resource links provided by NLM:

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Cerebral blood flow [ Time Frame: T1, 8-12 weeks of treatment, T2 ]

Secondary Outcome Measures:
  • Cognitive functioning assessed by neuropsychological testing [ Time Frame: T1, 8-12 weeks of treatment, T2-3 ]

Estimated Enrollment: 60
Study Start Date: September 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hypertensive elderly
community dwelling hypertensive elderly from general practices
Drug: anti-hypertensive medication
8-12 weeks of anti-hypertensive treatment with 2 weekly titration using registered hypertensive medication


Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age >= 70 years
  • Systolic office blood pressure >= 160 mmHg
  • Systolic home blood pressure >= 155 mmHg

Exclusion Criteria:

  • Diabetes Mellitus
  • Atrial fibrillation
  • Dementia
  • Renal failure requiring dialysis
  • Life expectancy of less than 1 year
  • Disabling stroke
  • Contraindication for MRI or anti-hypertensive medication
  • Systolic blood pressure > 220 mmHg
  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 identifier: NCT00966199

Contact: Jaap C Sijbesma, MD 0243616772 ext +31

Radboud University Not yet recruiting
Nijmegen, Gelderland, Netherlands, 6500HB
Contact: Jaap C Sijbesma, MD    0243616772 ext +31   
Sub-Investigator: Jaap C Sijbesma, MD         
Principal Investigator: Jurgen A Claassen, MD, PhD         
Sponsors and Collaborators
Radboud University
Dutch Heart Foundation
Principal Investigator: Jurgen A Claassen, MD, PhD Radboud University
  More Information

Responsible Party: J.A.H.R. Claassen, MD, PhD, Radboud University Nijmegen Medical Centre Identifier: NCT00966199     History of Changes
Other Study ID Numbers: MBRACE
Study First Received: August 17, 2009
Last Updated: August 25, 2009

Keywords provided by Radboud University:
blood pressure
cerebrovascular circulation

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents processed this record on September 21, 2017