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

This study is not yet open for participant recruitment.
Verified August 2009 by Radboud University
Sponsor:
Collaborator:
Dutch Heart Foundation
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00966199
First received: August 17, 2009
Last updated: August 25, 2009
Last verified: August 2009
History of Changes
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Cerebral blood flow [ Time Frame: T1, 8-12 weeks of treatment, T2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive functioning assessed by neuropsychological testing [ Time Frame: T1, 8-12 weeks of treatment, T2-3 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: August 17, 2009
Last Updated: August 25, 2009
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

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

ClinicalTrials.gov processed this record on May 16, 2013