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

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ClinicalTrials.gov Identifier: NCT00966199
Recruitment Status : Unknown
Verified August 2009 by Radboud University.
Recruitment status was:  Not yet recruiting
First Posted : August 26, 2009
Last Update Posted : August 26, 2009
Sponsor:
Collaborator:
Dutch Heart Foundation
Information provided by:
Radboud University

Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Drug: anti-hypertensive medication Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : September 2009
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00966199


Contacts
Contact: Jaap C Sijbesma, MD 0243616772 ext +31 J.Sijbesma@ger.umcn.nl

Locations
Netherlands
Radboud University Not yet recruiting
Nijmegen, Gelderland, Netherlands, 6500HB
Contact: Jaap C Sijbesma, MD    0243616772 ext +31    J.Sijbesma@ger.umcn.nl   
Sub-Investigator: Jaap C Sijbesma, MD         
Principal Investigator: Jurgen A Claassen, MD, PhD         
Sponsors and Collaborators
Radboud University
Dutch Heart Foundation
Investigators
Principal Investigator: Jurgen A Claassen, MD, PhD Radboud University

Responsible Party: J.A.H.R. Claassen, MD, PhD, Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT00966199     History of Changes
Other Study ID Numbers: MBRACE
2008B113
First Posted: August 26, 2009    Key Record Dates
Last Update Posted: August 26, 2009
Last Verified: August 2009

Keywords provided by Radboud University:
blood pressure
aging
cerebrovascular circulation
hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents