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

Primary Purpose

Hypertension

Status

Unknown status

Phase

Phase 4

Locations

Netherlands

Study Type

Interventional

Intervention

anti-hypertensive medication

About this trial

This is an interventional basic science trial for Hypertension focused on measuring blood pressure, aging, cerebrovascular circulation, hypertension

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Radboud University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hypertensive elderly

Arm Description

community dwelling hypertensive elderly from general practices

Outcomes

Primary Outcome Measures

Cerebral blood flow

Secondary Outcome Measures

Cognitive functioning assessed by neuropsychological testing

Full Information

NCT ID

NCT00966199

First Posted

August 17, 2009

Last Updated

August 25, 2009

Sponsor

Radboud University Medical Center

Collaborators

Dutch Heart Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00966199

Brief Title

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

Acronym

MBRACE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2009

Overall Recruitment Status

Unknown status

Study Start Date

September 2009 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Radboud University Medical Center

Collaborators

Dutch Heart Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

Keywords

blood pressure, aging, cerebrovascular circulation, hypertension

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hypertensive elderly

Arm Type

Experimental

Arm Description

community dwelling hypertensive elderly from general practices

Intervention Type

Drug

Intervention Name(s)

anti-hypertensive medication

Intervention Description

8-12 weeks of anti-hypertensive treatment with 2 weekly titration using registered hypertensive medication

Primary Outcome Measure Information:

Title

Cerebral blood flow

Time Frame

T1, 8-12 weeks of treatment, T2

Secondary Outcome Measure Information:

Title

Cognitive functioning assessed by neuropsychological testing

Time Frame

T1, 8-12 weeks of treatment, T2-3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jaap C Sijbesma, MD

Phone

0243616772

Ext

+31

J.Sijbesma@ger.umcn.nl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jurgen A Claassen, MD, PhD

Organizational Affiliation

Radboud University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Radboud University

City

Nijmegen

State/Province

Gelderland

ZIP/Postal Code

6500HB

Country

Netherlands

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jaap C Sijbesma, MD

Phone

0243616772

Ext

+31

J.Sijbesma@ger.umcn.nl

First Name & Middle Initial & Last Name & Degree

Jaap C Sijbesma, MD

First Name & Middle Initial & Last Name & Degree

Jurgen A Claassen, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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