NCT00497016

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started May 2007

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 6, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

September 30, 2008

Status Verified

September 1, 2008

First QC Date

July 4, 2007

Last Update Submit

September 29, 2008

Conditions

Hypertension

Keywords

hypertensionstatinsympathetic

Outcome Measures

Primary Outcomes (1)

  • change in central sympathetic activity

Secondary Outcomes (1)

  • change in cholesterol levels, renin and aldosteron

Interventions

atorvastatin 80 mgDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Medical Center Nijmegen

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 20953062DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Cees J Tack, MD, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 4, 2007

First Posted

July 6, 2007

Study Start

May 1, 2007

Study Completion

March 1, 2008

Last Updated

September 30, 2008

Record last verified: 2008-09

Locations

NL(1)