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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00132106
Other study ID # CHFALFA
Secondary ID
Status Recruiting
Phase N/A
First received August 18, 2005
Last updated August 30, 2007
Start date August 2005

Study information

Verified date August 2007
Source Radboud University
Contact Marc E.R. Gomes, MD
Phone +31-24-3614533/3616550
Email m.gomes@cardio.umcn.nl
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Heart failure of at least New York Heart Association (NYHA) class II

- Left ventricular ejection fraction (LVEF) <= 40%

- Age 18-75 years

Exclusion Criteria:

- 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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Drug:
phentolamine


Locations

Country Name City State
Netherlands Radboud University Nijmegen Medical Centre Nijmegen

Sponsors (2)

Lead Sponsor Collaborator
Radboud University ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in glucose uptake
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