The Effects of Blood Pressure Reduction on Cerebral Perfu... | NCT00966199

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

NCT00966199

Sponsor

Radboud University Medical Center

Status

Unknown status

Last Update Posted

Aug 26, 2009Estimated

Enrollment

60Estimated

Phase

Phase 4

Conditions

Hypertension

Interventions

anti-hypertensive medication

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2008B113

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Dec 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Aug 17, 2009

First Submission Date that Met QC Criteria

Aug 25, 2009

First Posted Date

Aug 26, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2009

Last Update Posted Date

Aug 26, 2009Estimated

Name	Class
Dutch Heart Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hypertensive elderly	Experimental	community dwelling hypertensive elderly from general practices	Drug: anti-hypertensive medication

Interventions

Name	Type	Description	Arm Group Labels	Other Names
anti-hypertensive medication	Drug	8-12 weeks of anti-hypertensive treatment with 2 weekly titration using registered hypertensive medication	Hypertensive elderly

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jaap C Sijbesma, MD	Contact	0243616772	+31	J.Sijbesma@ger.umcn.nl

Overall Officials

Name	Affiliation	Role
Jurgen A Claassen, MD, PhD	Radboud University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radboud University		Nijmegen	Gelderland	6500HB	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided