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

August 25, 2009 updated by: Radboud University Medical Center

Medication Induced Blood Pressure Reduction; Assessment of Cerebral Perfusion and Cognition in Hypertensive Elderly

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500HB
        • Radboud University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cerebral blood flow
Time Frame: T1, 8-12 weeks of treatment, T2
T1, 8-12 weeks of treatment, T2

Secondary Outcome Measures

Outcome Measure
Time Frame
Cognitive functioning assessed by neuropsychological testing
Time Frame: T1, 8-12 weeks of treatment, T2-3
T1, 8-12 weeks of treatment, T2-3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Dutch Heart Foundation

Investigators

  • Principal Investigator: Jurgen A Claassen, MD, PhD, Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

August 17, 2009

First Submitted That Met QC Criteria

August 25, 2009

First Posted (Estimate)

August 26, 2009

Study Record Updates

Last Update Posted (Estimate)

August 26, 2009

Last Update Submitted That Met QC Criteria

August 25, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBRACE
  • 2008B113

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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