NCT00966199

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
Completed

Started Sep 2009

Longer than P75 for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2009

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 26, 2009

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 26, 2009

Status Verified

August 1, 2009

Enrollment Period

4.3 years

First QC Date

August 17, 2009

Last Update Submit

August 25, 2009

Conditions

Hypertension

Keywords

blood pressureagingcerebrovascular circulationhypertension

Outcome Measures

Primary Outcomes (1)

  • Cerebral blood flow

    T1, 8-12 weeks of treatment, T2

Secondary Outcomes (1)

  • Cognitive functioning assessed by neuropsychological testing

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

Study Arms (1)

Hypertensive elderly

EXPERIMENTAL

community dwelling hypertensive elderly from general practices

Drug: anti-hypertensive medication

Interventions

anti-hypertensive medicationDRUG

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

Hypertensive elderly

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age \>= 70 years
  • Systolic office blood pressure \>= 160 mmHg
  • Systolic home blood pressure \>= 155 mmHg

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University

Nijmegen, Gelderland, 6500HB, Netherlands

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Jurgen A Claassen, MD, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaap C Sijbesma, MD

CONTACT

0243616772J.Sijbesma@ger.umcn.nl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 17, 2009

First Posted

August 26, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

August 26, 2009

Record last verified: 2009-08

Locations

NL(1)