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

• Sponsor: Radboud University Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00966199
• Collaborator: Dutch Heart Foundation (Other)
• Enrollment: 60
• Location: 1
• Arm: 1
• Duration (Months): 51
• Patients Per Site Per Month: 1.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: anti-hypertensive medication	Phase 4

Study Design

• Study Type: Interventional
• Anticipated 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: Sep 1, 2009
• Anticipated Primary Completion Date: Dec 1, 2013
• Anticipated Study Completion Date: Dec 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Cerebral blood flow [T1, 8-12 weeks of treatment, T2]

Secondary Outcome Measures

1. Cognitive functioning assessed by neuropsychological testing [T1, 8-12 weeks of treatment, T2-3]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Radboud University	Nijmegen	Gelderland	Netherlands	6500HB

Sponsors and Collaborators

• Radboud University Medical Center
• Dutch Heart Foundation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00966199
• Other Study ID Numbers: MBRACE; 2008B113
• First Posted: Aug 26, 2009
• Last Update Posted: Aug 26, 2009
• Last Verified: Aug 1, 2009

• Keywords provided by , ,: blood pressure; aging; cerebrovascular circulation; hypertension
• Additional relevant MeSH terms: Hypertension; Antihypertensive Agents

Study Results

No Results Posted as of Aug 26, 2009