Does Statin Therapy Reduce Sympathoexcitation in Hyperten... | NCT00497016

Studies
Does Statin Therapy Reduce Sympathoexcitation in Hypertension?

NCT00497016

Sponsor

Radboud University Medical Center

Status

Completed

Last Update Posted

Sep 30, 2008Estimated

Enrollment

13Estimated

Phase

Not Applicable

Conditions

Hypertension

Interventions

atorvastatin 80 mg

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

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Not provided

Completion Date

Mar 2008Actual

First Submitted Date

Jul 4, 2007

First Submission Date that Met QC Criteria

Jul 4, 2007

First Posted Date

Jul 6, 2007Estimated

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

Sep 29, 2008

Last Update Posted Date

Sep 30, 2008Estimated

Name	Class
ZonMw: The Netherlands Organisation for Health Research and Development	OTHER

Description Module

Brief Summary

A number of patients with hypertension have increased central sympathetic activity. Statins seem to inhibit central sympathetic output. This study assesses the effect of statins on central sympathetic activity in hypertension patients.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Estimated

Name	Type	Description	Arm Group Labels	Other Names
atorvastatin 80 mg	Drug

Measure	Description	Time Frame
change in central sympathetic activity

Measure	Description	Time Frame
change in cholesterol levels, renin and aldosteron

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

(Known) hypertension
stable drug therapy for at least 2 months
age 18-70 jaar
BMI 18-35 kg/m2
Sinusrhythm

Exclusion Criteria:

Recent cardiovascular event <6 mnd
Plasma Creatinin:
female: >120 mmol/L
male: >133 mmol/L
use of:
tricyclic antidepressants
alpha-1 -and/or alpha-2 blockers
disease of the autonomic nervous system (Parkinsons disease, Shy- Drager syndrome, etc)
Albuminuria >300 mg/dag

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cees J Tack, MD, PhD	Radboud University Medical Center	Principal Investigator

Locations

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20953062	Derived	Gomes ME, Tack CJ, Verheugt FW, Smits P, Lenders JW. Sympathoinhibition by atorvastatin in hypertensive patients. Circ J. 2010 Nov;74(12):2622-6. doi: 10.1253/circj.cj-10-0427. Epub 2010 Oct 9.

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds