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NCT00966199 Clinical Trial

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

Hypertension Clinical Trial

— MBRACE  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00966199
Other study ID # MBRACE
Secondary ID 2008B113
Status Not yet recruiting
Phase Phase 4
First received August 17, 2009
Last updated August 25, 2009
Start date September 2009
Est. completion date December 2013

Study information
Verified date August 2009
Source Radboud University
Contact Jaap C Sijbesma, MD
Phone 0243616772
Email J.Sijbesma@ger.umcn.nl
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 70 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Netherlands Radboud University Nijmegen Gelderland

Sponsors (2)
Lead Sponsor Collaborator
Radboud University Dutch Heart Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cerebral blood flow T1, 8-12 weeks of treatment, T2 No
Secondary Cognitive functioning assessed by neuropsychological testing T1, 8-12 weeks of treatment, T2-3 No
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