NCT00550121

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Aug 2007

Shorter than P25 for not_applicable heart-failure

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

August 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

October 15, 2008

Status Verified

October 1, 2008

First QC Date

October 25, 2007

Last Update Submit

October 13, 2008

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • change in central sympathetic output after vitamin C vs. placebo

Study Arms (2)

1

EXPERIMENTAL
Drug: vitamin C

2

PLACEBO COMPARATOR
Drug: placebo

Interventions

vitamin CDRUG
1
placeboDRUG
2

Eligibility Criteria

Age20 Years - 80 Years
Sexall
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 20-80 years

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Cees J Tack, MD, PhD

    Radboud University Medical Centre Nijmegen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 25, 2007

First Posted

October 26, 2007

Study Start

August 1, 2007

Study Completion

April 1, 2008

Last Updated

October 15, 2008

Record last verified: 2008-10

Locations

NL(1)