NCT00132106

Brief Summary

The activity of the sympathetic nervous system seems to influence the uptake (and handling) of glucose by the skeletal muscle of the forearm. Conditions in which sympathetic activity is increased seem to inhibit/reduce forearm glucose uptake. Inversely a decrease in sympathetic activity seems to increase glucose uptake. This study analyzes the effect of alfa-adrenergic receptor blockade (counteracting sympathetic influence) on insulin-stimulated forearm glucose uptake in patients with increased sympathetic activity (patients with chronic heart failure).

Trial Health

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Trial Health Score

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

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2005

Completed
Last Updated

August 31, 2007

Status Verified

August 1, 2007

First QC Date

August 18, 2005

Last Update Submit

August 30, 2007

Conditions

Heart Failure, Congestive

Outcome Measures

Primary Outcomes (1)

  • change in glucose uptake

Interventions

phentolamineDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Heart failure of at least New York Heart Association (NYHA) class II
  • Left ventricular ejection fraction (LVEF) \<= 40%
  • Age 18-75 years

You may not qualify if:

  • Alfa-blockers, or beta-blockers with alfa-blocking activity (carvedilol)
  • Tricyclic antidepressants
  • Warfarin derivatives (acetylic salicylic acid and clopidogrel are allowed)
  • Hospitalisation in 6 weeks prior to the study
  • Any change in medication in 6 weeks prior to the study
  • Unstable angina
  • Orthopnoea
  • Known chronic disease of the autonomic nervous system
  • Diabetes mellitus
  • Oedema of the lower extremities, complicating the insertion of a venous catheter in a vein on the foot

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Phentolamine

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Cees J Tack, MD, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc E.R. Gomes, MD

CONTACT

+31-24-3614533/3616550m.gomes@cardio.umcn.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 18, 2005

First Posted

August 19, 2005

Study Start

August 1, 2005

Last Updated

August 31, 2007

Record last verified: 2007-08

Locations

NL(1)