Does Ascorbic Acid Reduce Sympathoexcitation in CHF?

October 13, 2008 updated by: Radboud University Medical Center
In CHF central sympathetic activity is increased. ROS formation seems to play a role in this process. This study analyzes the effect of vitamin C as an antioxidant on central sympathetic activity in CHF

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nijmegen, Netherlands, 6500 HB
        • Radboud University Nijmegen Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Heart failure of at least New York Heart Association (NYHA) class II
  • Left ventricular ejection fraction (LVEF) <= 40%
  • Age 20-80 years

Exclusion Criteria:

  • Necessity of short-term PCI, CABG or heart transplantation,
  • Chronic disease of the autonomic nervous system,
  • diabetes mellitus,
  • use of tricyclic antidepressant drugs and/or a-adrenergic receptor antagonists.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: vitamin C
Placebo Comparator: 2
Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
change in central sympathetic output after vitamin C vs. placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

  • Principal Investigator: Cees J Tack, MD, PhD, Radboud University Medical Centre Nijmegen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

October 25, 2007

First Submitted That Met QC Criteria

October 25, 2007

First Posted (Estimate)

October 26, 2007

Study Record Updates

Last Update Posted (Estimate)

October 15, 2008

Last Update Submitted That Met QC Criteria

October 13, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHFVIT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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